Method and apparatus for manipulating the side wall of a body lumen or body cavity so as to provide increased visualization of the same and/or increased access to the same, and/or for stabilizing instruments relative to the same

ABSTRACT

Apparatus comprising: a sleeve adapted to be slid over the exterior of an endoscope; an aft balloon secured to the sleeve; an inflation/deflation tube carried by the sleeve and in fluid communication with the interior of the aft balloon; a pair of hollow push tubes slidably mounted to the sleeve, the pair of hollow push tubes being connected to one another at their distal ends with a raised push tube bridge, the raised push tube bridge being configured to nest an endoscope therein; and a fore balloon secured to the distal ends of the pair of hollow push tubes, the interior of the fore balloon being in fluid communication with the interiors of the pair of hollow push tubes, wherein the fore balloon is capable of assuming a deflated condition and an inflated condition, and further wherein (i) when the fore balloon is in its deflated condition, an axial opening extends therethrough, the axial opening being sized to receive the endoscope therein, and (ii) when the fore balloon is in its inflated condition, the axial opening is closed down.

REFERENCE TO PENDING PRIOR PATENT APPLICATIONS

This patent application:

(1) is a continuation-in-part of pending prior U.S. patent applicationSer. No. 14/619,845, filed Feb. 11, 2015 by Cornell University and JohnFrederick Cornhill et al. for METHOD AND APPARATUS FOR MANIPULATING THESIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASEDVISUALIZATION OF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/ORFOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME, which patentapplication:

-   -   (A) is a continuation-in-part of pending prior U.S. patent        application Ser. No. 14/540,355, filed Nov. 13, 2014 by Cornell        University and Jeffrey Milsom et al. for METHOD AND APPARATUS        FOR STABILIZING, STRAIGHTENING, EXPANDING AND/OR FLATTENING THE        SIDE WALL OF A BODY LUMEN AND/OR BODY CAVITY SO AS TO PROVIDE        INCREASED VISUALIZATION OF THE SAME AND/OR INCREASED ACCESS TO        THE SAME, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE TO THE        SAME, which patent application:        -   (i) is a continuation of prior U.S. patent application Ser.            No. 12/969,059, filed Dec. 15, 2010 by Jeffrey Milsom et al.            for METHOD AND APPARATUS FOR STABILIZING, STRAIGHTENING,            EXPANDING AND/OR FLATTENING THE SIDE WALL OF A BODY LUMEN            AND/OR BODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATION            OF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR            STABILIZING INSTRUMENTS RELATIVE TO THE SAME, which patent            application:            -   (a) claims benefit of prior U.S. Provisional Patent                Application Ser. No. 61/284,215, filed Dec. 15, 2009 by                Jeffrey Milsom et al. for METHOD AND APPARATUS FOR                STABILIZING, STRAIGHTENING, EXPANDING AND/OR FLATTENING                THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO                PROVIDE INCREASED VISUALIZATION OF THE SIDE WALL OF THE                BODY LUMEN OR BODY CAVITY, AND/OR FOR STABILIZING                INSTRUMENTS RELATIVE TO THE SAME; and    -   (B) claims benefit of prior U.S. Provisional Patent Application        Ser. No. 61/938,446, filed Feb. 11, 2014 by Cornell University        and John Frederick Cornhill et al. for METHOD AND APPARATUS FOR        MANIPULATING THE SIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS        TO PROVIDE INCREASED VISUALIZATION OF THE SAME AND/OR INCREASED        ACCESS TO THE SAME, AND/OR FOR STABILIZING INSTRUMENTS RELATIVE        TO THE SAME;

(2) claims benefit of pending prior U.S. Provisional Patent ApplicationSer. No. 62/170,476, filed Jun. 3, 2015 by Lumendi Ltd. and JohnFrederick Cornhill et al. for METHOD AND APPARATUS FOR MANIPULATING THESIDE WALL OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASEDVISUALIZATION OF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/ORFOR STABILIZING INSTRUMENTS RELATIVE TO THE SAME;

(3) claims benefit of pending prior U.S. Provisional Patent ApplicationSer. No. 62/170,497, filed Jun. 3, 2015 by Lumendi Ltd. and StephenEvans et al. for METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OFA BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OFTHE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZINGINSTRUMENTS RELATIVE TO THE SAME;

(4) claims benefit of pending prior U.S. Provisional Patent ApplicationSer. No. 62/244,008, filed Oct. 20, 2015 by Lumendi Ltd. and AlanFortunate et al. for METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALLOF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATIONOF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZINGINSTRUMENTS RELATIVE TO THE SAME;

(5) claims benefit of pending prior U.S. Provisional Patent ApplicationSer. No. 62/244,214, filed Oct. 21, 2015 by Lumendi Ltd. and Audrey Bellet al. for METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF A BODYLUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OF THESAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZINGINSTRUMENTS RELATIVE TO THE SAME;

(6) claims benefit of pending prior U.S. Provisional Patent ApplicationSer. No. 62/305,773, filed Mar. 9, 2016 by Lumendi Ltd. and AlanFortunate for METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF ABODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OFTHE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZINGINSTRUMENTS RELATIVE TO THE SAME, INCLUDING VENTING OF BALLOONS THROUGHPACKAGING DESIGN;

(7) claims benefit of pending prior U.S. Provisional Patent ApplicationSer. No. 62/305,797, filed Mar. 9, 2016 by Lumendi Ltd. and Brian DavidChouinard for METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALL OF ABODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATION OFTHE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZINGINSTRUMENTS RELATIVE TO THE SAME, INCLUDING IMPROVED AFT BALLOON THERMALBONDING USING INSERT MATERIAL; and

(8) claims benefit of pending prior U.S. Provisional Patent ApplicationSer. No. 62/305,804, filed Mar. 9, 2016 by Lumendi Ltd. and Brian DavidChouinard et al. for METHOD AND APPARATUS FOR MANIPULATING THE SIDE WALLOF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE INCREASED VISUALIZATIONOF THE SAME AND/OR INCREASED ACCESS TO THE SAME, AND/OR FOR STABILIZINGINSTRUMENTS RELATIVE TO THE SAME, INCLUDING IMPROVED FORE BALLOONCONSTRUCTION;

The twelve (12) above-identified patent applications are herebyincorporated herein by reference.

FIELD OF THE INVENTION

This invention relates to surgical methods and apparatus in general, andmore particularly to surgical methods and apparatus for manipulating theside wall of a body lumen and/or body cavity so as to provide increasedvisualization of the same and/or increased access to the same, and/orfor stabilizing instruments relative to the same.

BACKGROUND OF THE INVENTION

The human body comprises many different body lumens and body cavities.By way of example but not limitation, the human body comprises bodylumens such as the gastrointestinal (GI) tract, blood vessels, lymphaticvessels, the urinary tract, fallopian tubes, bronchi, bile ducts, etc.By way of further example but not limitation, the human body comprisesbody cavities such as the head, chest, abdomen, nasal sinuses, bladder,cavities within organs, etc.

In many cases it may be desirable to endoscopically examine and/or treata disease process or abnormality which is located within, or on the sidewall of, a body lumen and/or body cavity. By way of example but notlimitation, it may be desirable to examine the side wall of thegastrointestinal tract for lesions and, if a lesion is found, to biopsy,remove and/or otherwise treat the lesion.

The endoscopic examination and/or treatment of the side wall of a bodylumen and/or body cavity can be complicated by the anatomicconfiguration (both regional and local) of the side wall of the bodylumen and/or body cavity, and/or by the consistency of the tissue makingup the side wall of the body lumen and/or body cavity, and/or by thetethering of the side wall of the body lumen and/or body cavity to otheranatomical structures.

By way of example but not limitation, the intestine is an elongatedtubular organ having an inner lumen and is characterized by frequentturns (i.e., the regional anatomic configuration of the intestine), andcomprises a side wall characterized by numerous folds (i.e., the localanatomic configuration of the intestine), with the side wall tissuehaving a relatively soft, pliable consistency, and with the colon inparticular being tethered to the abdomen and/or other abdominalstructures via soft tissue. It can be difficult to fully visualize theside wall of the intestine, and/or to treat a lesion formed on the sidewall of the intestine, due to this varying side wall anatomicconfiguration (both regional and local), its relatively soft, pliableconsistency, and its tethering to other anatomical structures via softtissue. By way of example but not limitation, in the case ofcolonoscopies, it has been found that approximately 5-40% of patientshave an anatomic configuration (regional and/or local) of the side wall,and/or a tissue consistency, and/or colon tethering to other anatomicalstructures, which makes it difficult to fully visualize the anatomy(including pathologic conditions of that anatomy, such as polyps ortumors) using conventional endoscopes, and/or to fully access theanatomy using instruments introduced through conventional endoscopes.

In addition to the foregoing, it has also been found that some bodylumens and/or body cavities can spasm and/or contract. This spasmingand/or contraction can occur spontaneously, but it is particularlycommon when an endoscope or other instrument is inserted into the bodylumen and/or body cavity. This spasming and/or contraction can cause thebody lumen and/or body cavity to constrict and/or otherwise move and/orchange its configuration, which can further complicate and/or compromiseendoscopic visualization of the anatomy, and/or further complicateand/or compromise access to the anatomy using instruments introducedthrough conventional, flexible endoscopes. In addition, duringexamination of the colon, which is typically conducted while bothadvancing and withdrawing the endoscope through the colon, the endoscopemay grip and/or otherwise gather the colon during advancement and/orwithdrawal and then suddenly slip and release the colon. This grippingand then sudden release of the colon can result in the endoscope movingquickly past significant lengths of the colon, thereby making accurateexamination of the colon challenging.

It would, therefore, be highly advantageous to provide novel apparatuscapable of manipulating the side wall of a body lumen and/or body cavityso as to better present the side wall tissue (including visualization ofareas which may be initially hidden from view or outside the field ofview) for examination and/or treatment during an endoscopic procedure.

It would also be highly advantageous to provide novel apparatus capableof steadying and/or stabilizing the distal tips and/or working ends ofinstruments (e.g., endoscopes, articulating and/or non-articulatingdevices such as graspers, cutters or dissectors, cauterizing tools,ultrasound probes, etc.) inserted into a body lumen and/or body cavitywith respect to the side wall of the body lumen and/or body cavity,whereby to facilitate the precision use of those instruments.

Among other things, it would be highly advantageous to provide novelapparatus capable of steadying and/or stabilizing the distal tips and/orworking ends of endoscopes (and hence also steadying and/or stabilizingthe distal tips and/or working ends of other instruments insertedthrough the working channels of those endoscopes, such as graspers,cutters or dissectors, cauterizing tools, ultrasound probes, etc.).

And it would be highly advantageous to provide novel apparatus capableof steadying and/or stabilizing the distal tips and/or working ends ofinstruments (such as graspers, cutters or dissectors, cauterizing tools,ultrasound probes, etc.) advanced to the surgical site by means otherthan through the working channels of endoscopes.

It would also be highly advantageous to be able to straighten bends,“iron out” inner luminal surface folds and create a substantially staticor stable side wall of the body lumen and/or body cavity, whereby toenable more precise visual examination (including visualization of areaswhich may be initially hidden from view or outside the field of view)and/or therapeutic intervention.

SUMMARY OF THE INVENTION

The present invention comprises the provision and use of novel apparatusfor manipulating the side wall of a body lumen and/or body cavity so asto better present the side wall tissue (including visualization of areaswhich may be initially hidden from view or outside the field of view)for examination and/or treatment during an endoscopic procedure.

The present invention also comprises the provision and use of novelapparatus capable of steadying and/or stabilizing the distal tips and/orworking ends of instruments (e.g., endoscopes, articulating and/ornon-articulating devices such as graspers, cutters or dissectors,cauterizing tools, ultrasound probes, etc.) inserted into a body lumenand/or body cavity with respect to the side wall of the body lumenand/or body cavity, whereby to facilitate the precision use of thoseinstruments.

Among other things, the present invention comprises the provision anduse of novel apparatus capable of steadying and/or stabilizing thedistal tips and/or working ends of endoscopes (and hence also steadyingand/or stabilizing the distal tips and/or working ends of otherinstruments inserted through the working channels of those endoscopes,such as graspers, cutters or dissectors, cauterizing tools, ultrasoundprobes, etc.).

And the present invention comprises the provision and use of novelapparatus capable of steadying and/or stabilizing the distal tips and/orworking ends of instruments (such as graspers, cutters or dissectors,cauterizing tools, ultrasound probes, etc.) advanced to the surgicalsite by means other than through the working channels of endoscopes.

And the present invention comprises the provision and use of novelapparatus capable of straightening bends, “ironing out” folds andcreating a substantially static or stable side wall of the body lumenand/or body cavity which enables more precise visual examination(including visualization of areas which may be initially hidden fromview or outside the field of view) and/or therapeutic intervention.

In one preferred form of the present invention, there is providedapparatus comprising:

a sleeve adapted to be slid over the exterior of an endoscope;

an aft balloon secured to the sleeve;

an inflation/deflation tube carried by the sleeve and in fluidcommunication with the interior of the aft balloon;

a pair of hollow push tubes slidably mounted to the sleeve, the pair ofhollow push tubes being connected to one another at their distal endswith a raised push tube bridge, the raised push tube bridge beingconfigured to nest an endo scope therein; and

a fore balloon secured to the distal ends of the pair of hollow pushtubes, the interior of the fore balloon being in fluid communicationwith the interiors of the pair of hollow push tubes, wherein the foreballoon is capable of assuming a deflated condition and an inflatedcondition, and further wherein (i) when the fore balloon is in itsdeflated condition, an axial opening extends therethrough, the axialopening being sized to receive the endoscope therein, and (ii) when thefore balloon is in its inflated condition, the axial opening is closeddown.

In another preferred form of the present invention, there is provided amethod for performing a procedure in a body lumen and/or body cavity,the method comprising:

providing apparatus comprising:

-   -   a sleeve adapted to be slid over the exterior of an endoscope;    -   an aft balloon secured to the sleeve;    -   an inflation/deflation tube carried by the sleeve and in fluid        communication with the interior of the aft balloon;    -   a pair of hollow push tubes slidably mounted to the sleeve, the        pair of hollow push tubes being connected to one another at        their distal ends with a raised push tube bridge, the raised        push tube bridge being configured to nest an endo scope therein;        and    -   a fore balloon secured to the distal ends of the pair of hollow        push tubes, the interior of the fore balloon being in fluid        communication with the interiors of the pair of hollow push        tubes, wherein the fore balloon is capable of assuming a        deflated condition and an inflated condition, and further        wherein (i) when the fore balloon is in its deflated condition,        an axial opening extends therethrough, the axial opening being        sized to receive the endoscope therein, and (ii) when the fore        balloon is in its inflated condition, the axial opening is        closed down;

positioning an endoscope in the sleeve so that the endoscope nests inthe push tube bridge;

positioning the apparatus in the body lumen and/or body cavity;

inflating the aft balloon;

advancing the pair of push tubes distally;

inflating the fore balloon; and

performing the procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other objects and features of the present invention will bemore fully disclosed or rendered obvious by the following detaileddescription of the preferred embodiments of the invention, which is tobe considered together with the accompanying drawings wherein likenumbers refer to like parts and further wherein:

FIG. 1 is a schematic view showing novel apparatus formed in accordancewith the present invention, wherein the novel apparatus comprises, amongother things, a sleeve for disposition over the end of an endoscope, anaft balloon mounted to the sleeve, a pair of hollow push tubes slidablymounted to the sleeve, the pair of hollow push tubes being connected toone another at their distal ends with a raised push tube bridge, theraised push tube bridge being configured to nest an endoscope therein, afore balloon mounted to the distal end of the hollow push tubes, and apush tube handle mounted to the proximal ends of the hollow push tubes;

FIGS. 2-4 are schematic views showing various dispositions of the foreballoon relative to the aft balloon;

FIG. 5 is a schematic view showing further details of the distal end ofthe apparatus shown in FIG. 1;

FIG. 6 is a section view taken along line 6-6 of FIG. 5;

FIGS. 7 and 8 are schematic views showing a pair of hollow push tubes, araised push tube bridge, and the fore balloon;

FIGS. 9-11 are schematic views showing a pair of hollow push tubes and araised push tube bridge formed in accordance with the present invention;

FIG. 12 is a schematic view showing another pair of hollow push tubesand a raised push tube bridge formed in accordance with the presentinvention;

FIG. 13 is a schematic view showing another pair of hollow push tubesand a raised push tube bridge formed in accordance with the presentinvention;

FIG. 14 is a schematic view showing another pair of hollow push tubesand a raised push tube bridge formed in accordance with the presentinvention;

FIGS. 15 and 16 are schematic views showing further details of the foreballoon;

FIG. 17 is a schematic view showing the push tube handle;

FIGS. 18 and 19 are schematic views showing construction details of thefore balloon;

FIGS. 20-34 are schematic views showing another form of the handlemechanism for the novel apparatus of the present invention;

FIG. 35 is a schematic view showing one form of inflation mechanismprovided in accordance with the present invention;

FIG. 36 is a schematic view showing another form of inflation mechanismprovided in accordance with the present invention;

FIGS. 37 and 38 are schematic views showing another form of inflationmechanism provided in accordance with the present invention;

FIGS. 39-58 are schematic views showing another form of inflationmechanism provided in accordance with the present invention;

FIG. 59 is a schematic view showing relief valves which may be used toensure that the pressure within the fore balloon and/or aft balloon doesnot exceed a predetermined level;

FIG. 60 is a schematic view showing a retraction system which may beused to take up slack in a flexible tube of the apparatus shown in FIG.1;

FIGS. 61-82 are schematic views showing novel apparatus for inflatingand deflating balloons;

FIG. 83 is a schematic view showing the novel apparatus of the presentinvention sealed within a novel package formed in accordance with thepresent invention;

FIG. 84 is a schematic view showing details of a novel inflationmechanism formed in accordance with the present invention;

FIG. 85-88 are schematic views showing further details of the novelpackage of FIG. 83 and further details of the novel inflation mechanismof FIG. 84;

FIGS. 89-107 are schematic views showing preferred ways of using theapparatus of FIG. 1;

FIG. 108 is a cross-sectional schematic view showing how gaps arecreated between (i) the sleeve, (ii) the push rod lumens, and (iii) theaft balloon inflation lumen of the apparatus of FIGS. 1-106;

FIG. 109 is a cross-sectional schematic view similar to FIG. 108,showing a plurality of novel extruded inserts filling the aforementionedgaps between the sleeve, the push rod lumens and the aft ballooninflation lumen, whereby to facilitate airtight bonding of the aftballoon to the assembly;

FIGS. 110, 111 and 112 are schematic views showing novel extrudedinserts formed in accordance with the present invention;

FIGS. 113 and 114 are schematic views showing the novel extruded insertsof FIGS. 110, 111 and 112 disposed along the sheath of the apparatus ofFIGS. 1-106 so as to fill the gaps between the sleeve, the push rodlumens and aft balloon inflation lumen;

FIGS. 115-122 are schematic views showing an alternative constructionfor the fore balloon;

FIG. 123 is a schematic view showing another alternative constructionfor the fore balloon;

FIGS. 124 and 125 are schematic views showing an alternativeconstruction for the aft balloon;

FIG. 126 is a schematic view showing an alternative construction for thehollow push tubes and push tube handle of the present invention;

FIG. 127 is a schematic view showing another form of the sleeve, whereinthe sleeve comprises additional lumens for receiving instruments;

FIGS. 128-131 are schematic views showing how instruments may beadvanced through the additional lumens of the sleeve; and

FIG. 132 is a schematic view showing instrument guide tubes which may bedisposed in the additional lumens of the sleeve, wherein instruments maybe advanced through the instrument guide tubes.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention comprises the provision and use of novel apparatusfor manipulating the side wall of a body lumen and/or body cavity so asto better present the side wall tissue (including visualization of areasinitially hidden or outside the field of view) for examination and/ortreatment during an endoscopic procedure.

(As used herein, the term “endoscopic procedure” is intended to meansubstantially any minimally-invasive or limited access procedure,diagnostic and/or therapeutic and/or surgical, for accessing,

endoluminally or transluminally or otherwise, the interior of a bodylumen and/or body cavity for the purposes of viewing, biopsying and/ortreating tissue, including removing a lesion and/or resecting tissue,etc.)

The present invention also comprises the provision and use of novelapparatus capable of steadying and/or stabilizing the distal tips and/orworking ends of instruments (e.g., endoscopes, articulating and/ornon-articulating devices such as graspers, cutters or dissectors,cauterizing tools, ultrasound probes, etc.) inserted into a body lumenand/or body cavity with respect to the side wall of the body lumenand/or body cavity, whereby to facilitate the precision use of thoseinstruments.

Among other things, the present invention comprises the provision anduse of novel apparatus capable of steadying and/or stabilizing thedistal tips and/or working ends of endoscopes (and hence also steadyingand/or stabilizing the distal tips and/or working ends of otherinstruments inserted through the working channels of those endoscopes,such as graspers, cutters or dissectors, cauterizing tools, ultrasoundprobes, etc.).

And the present invention comprises the provision and use of novelapparatus capable of steadying and/or stabilizing the distal tips and/orworking ends of instruments (such as graspers, cutters or dissectors,cauterizing tools, ultrasound probes, etc.) advanced to the surgicalsite by means other than through the working channels of endoscopes.

And the present invention comprises the provision and use of novelapparatus capable of straightening bends, “ironing out” folds andcreating a substantially static or stable side wall of the body lumenand/or body cavity which enables more precise visual examination(including visualization of areas which may be initially hidden fromview or outside the field of view) and/or therapeutic intervention.

The Novel Apparatus

In accordance with the present invention, and looking now at FIG. 1,there is shown novel apparatus 5 which is capable of manipulating (e.g.,stabilizing, straightening, expanding and/or flattening, etc.) the sidewall of a body lumen and/or body cavity so as to better present the sidewall tissue (including visualization of areas which may be initiallyhidden from view or outside the field of view) for examination and/ortreatment during an endoscopic procedure using an endoscope 10 (e.g., anarticulating endoscope), and/or for stabilizing the distal end ofendoscope 10 and/or the distal tips and/or working ends of otherinstruments (e.g., graspers, cutters or dissectors, cauterizing tools,ultrasound probes, etc., not shown in FIG. 1).

More particularly, apparatus 5 generally comprises a sleeve 15 adaptedto be slid over the exterior of the shaft of endoscope 10, a proximal(or “aft”) balloon 20 (the terms “proximal” and “aft” will hereinafterbe used interchangeably) secured to sleeve 15 near the distal end of thesleeve, and a base 25 secured to sleeve 15 at the proximal end of thesleeve. Apparatus 5 also comprises a pair of hollow push tubes 30slidably mounted to sleeve 15 as will hereinafter be discussed, the pairof hollow push tubes being connected to one another at their distal endswith a raised push tube bridge 31, the raised push tube bridge 31 beingconfigured to nest an endoscope therein, and a distal (or “fore”)balloon 35 (the terms “distal” and “fore” will hereinafter be usedinterchangeably) secured to the distal ends of hollow push tubes 30,such that the spacing between aft balloon 20 and fore balloon 35 can beadjusted by the physician (or other operator or user) by moving hollowpush tubes 30 relative to sleeve 15 (e.g., by advancing the two hollowpush tubes simultaneously at push tube handle 37, see below). See FIGS.1 and 2-4. Apparatus 5 also comprises an associated inflation mechanism40 (FIG. 1) for enabling selective inflation/deflation of one or both ofaft balloon 20 and fore balloon 35 by the physician (or other operatoror user).

The Sleeve

Looking now at FIGS. 1-6, sleeve 15 generally comprises an elongated,thin-walled tube configured to be slid over the exterior of the shaft ofendo scope 10 (e.g., retrograde from the distal tip of the endoscope) soas to make a close fit therewith, with the sleeve being sized andconstructed so that it will slide easily back over the endoscope duringmounting thereon (preferably with the scope “dry”) but will havesufficient residual friction (when gripped by the hand of the physicianor other operator or user) with the outer surface of the endoscope suchthat the sleeve will remain in place to allow torqueing (i.e.,rotational turning) and pushing/pulling of the endoscope during use(e.g., within the colon of a patient). In one preferred form of theinvention, sleeve 15 can move circumferentially to some extent aboutendoscope 10 (and when gripped securely by the hand of the physician orother operator or user, can rotate in conjunction with the shaft of theendoscope); but sleeve 15 can only move nominally in an axial directionrelative to endoscope 10. Sleeve 15 is sized so that when its distal endis substantially aligned with the distal end of endoscope 10, sleeve 15(in conjunction with base 25) will substantially cover the shaft of theendoscope. In any case, sleeve 15 is sized so that when it is mounted toendoscope 10 and endoscope 10 is inserted into a patient, sleeve 15extends out of the body of the patient. In one preferred form of theinvention, apparatus 5 is provided according to the particular endoscopewith which it is intended to be used, with apparatus 5 being sized sothat when base 25 is in engagement with the handle of the endoscope, thedistal end of sleeve 15 will be appropriately positioned at the distalend of the endoscope, i.e., substantially aligned with the distal end ofthe endoscope or slightly proximal to the distal end of the endoscope.

If desired, the distal end of sleeve 15 may be provided with aradially-inwardly-extending stop (not shown) to positively engage thedistal end surface of endoscope 10, whereby to prevent the distal end ofsleeve 15 from moving proximally beyond the distal end surface ofendoscope 10. Such a radially-inwardly-extending stop can also assist inpreventing “torque slip” of sleeve 15 relative to endoscope 10 duringtorqueing (i.e., rotational turning) of the endoscope while within thecolon, and/or “thrust slip” of sleeve 15 relative to endoscope 10 duringforward pushing of the endoscope while within the colon.

Sleeve 15 preferably has a smooth outer surface so as to benon-traumatic to tissue, and is preferably made of a highly flexiblematerial such that the sleeve will not inhibit bending of the endoscopeduring use. In one preferred form of the invention, sleeve 15 comprisespolyurethane, polyethylene, poly(vinyl chloride) (PVC),polytetrafluoroethylene (PTFE), etc., and is preferably transparent (orat least translucent) so as to allow distance markings on endoscope 10to be visualized through sleeve 15. And in one preferred form of theinvention, sleeve 15 preferably has nominal hoop strength, so that thephysician (or other operator or user) can grip endoscope 10 throughsleeve 15, e.g., so as to torque the scope. If desired, sleeve 15 caninclude a lubricious coating (e.g., a liquid such as perfluoropolyethersynthetic oil, a powder, etc.) on some or all of its interior and/orexterior surfaces, so as to facilitate disposition of the sleeve overthe endoscope and/or movement of apparatus 5 through a body lumen and/orbody cavity. Alternatively, sleeve 15 may be formed of a material whichis itself lubricious, e.g., polytetrafluoroethylene (PTFE), etc. Itshould be appreciated that the inside surface of sleeve 15 may includefeatures (e.g., ribs) to prevent the sleeve from rotating relative tothe endoscope during use.

If desired, a vacuum may be “pulled” between sleeve 15 and endoscope 10,whereby to secure sleeve 15 to endoscope 10 and minimize the profile ofsleeve 15. By way of example but not limitation, a vacuum may beintroduced at the proximal end of sleeve 15 (i.e., at base 25) or avacuum may be introduced at a point intermediate sleeve 15. By way offurther example but not limitation, it should also be appreciated thatremoval of sleeve 15 from endoscope 10 (e.g., at the conclusion of aprocedure) may be facilitated by introducing a fluid (e.g., air or aliquid lubricant) into the space between sleeve 15 and endoscope 10,e.g., at the proximal end of sleeve 15 (i.e., at base 25) orintermediate sleeve 15.

The Aft Balloon

Still looking now at FIGS. 1-6, aft balloon 20 is secured to sleeve 15just proximal to the articulating joint of the endoscope near to, butspaced from, the distal end of the sleeve. Aft balloon 20 is disposedconcentrically about sleeve 15, and hence concentrically about anendoscope 10 disposed within sleeve 15. Thus, aft balloon 20 has agenerally toroidal shape. Aft balloon 20 may be selectivelyinflated/deflated by means of a proximal inflation/deflation tube 45which has its distal end in fluid communication with the interior of aftballoon 20, and which has its proximal end in fluid communication with afitting 46 mounted to base 25. Fitting 46 is configured for connectionto the aforementioned associated inflation mechanism 40. Fitting 46 ispreferably a luer-activated valve, allowing inflation mechanism 40 to bedisconnected from fitting 46 without losing pressure in aft balloon 20.Inflation/deflation tube 45 may be secured to the exterior surface ofsleeve 15 or, more preferably, inflation/deflation tube 45 may becontained within a lumen 47 formed within sleeve 15.

Preferably aft balloon 20 is disposed a short distance back from thedistal end of sleeve 15, i.e., by a distance which is approximately thesame as the length of the articulating portion of a steerable endoscope10, such that the articulating portion of the steerable endoscope willbe disposed distal to aft balloon 20 when the steerable endoscope isdisposed in sleeve 15. This construction allows the flexible portion ofthe steerable endoscope to be articulated even when aft balloon has beeninflated in the anatomy so as to stabilize the adjacent non-articulatingportion of the endoscope relative to the anatomy, as will hereinafter bediscussed in further detail. Thus, when inflated, aft balloon 20provides a secure platform within the anatomy for maintaining endoscope10 in a stable position within a body lumen or body cavity, withendoscope 10 centered within the body lumen or body cavity. As a result,endoscope 10 can provide improved visualization of the anatomy.Furthermore, inasmuch as endoscope 10 is securely maintained within thebody lumen or body cavity by the inflated aft balloon 20, instrumentsadvanced through the internal lumens (sometimes referred to as the“working channel” or “working channels”) of endoscope 10 will also beprovided with a secure platform for supporting those instruments withinthe body lumen or body cavity.

When aft balloon 20 is appropriately inflated, the aft balloon canatraumatically engage and form a sealing relationship with the side wallof a body lumen within which apparatus 5 is disposed.

In one preferred form of the invention, aft balloon 20 is formed out ofpolyurethane.

The Base

Base 25 is secured to the proximal end of sleeve 15. Base 25 engagesendoscope 10 and helps secure the entire assembly (i.e., apparatus 5) toendoscope 10. Base 25 preferably comprises a substantially rigid orsemi-rigid structure which may be gripped by the physician (or otheroperator or user) and pulled proximally, whereby to allow the physician(or other operator or user) to pull sleeve 15 over the distal end ofendoscope 10 and then proximally back along the length of endoscope 10,whereby to mount sleeve 15 to the outer surface of the shaft of theendoscope. In one preferred form of the invention, base 25 is pulledproximally along the endoscope until base 25 seats against the handle ofthe endoscope, thereby prohibiting further proximal movement of base 25(and hence thereby prohibiting further proximal movement of sleeve 15).In one preferred form of the invention, base 25 makes a sealingengagement with endoscope 10.

The Pair of Hollow Push Tubes and the Push Tube Handle

The pair of hollow push tubes 30 are slidably mounted to sleeve 15,whereby the distal ends of the hollow push tubes (and the raised pushtube bridge 31 connecting the distal ends of the pair of hollow pushtubes 30) can be extended and/or retracted relative to sleeve 15 (e.g.,by advancing or withdrawing the hollow push tubes via push tube handle37, see below), and hence extended and/or retracted relative to thedistal end of endoscope 10 which is disposed in sleeve 15. Preferably,hollow push tubes 30 are slidably disposed in support tubes 50 which aresecured to the outer surface of sleeve 15 or, more preferably, arecontained within lumens 52 formed within sleeve 15. Support tubes 50 arepreferably formed out of a low friction material (e.g.,polytetrafluoroethylene, also known as “PTFE”) so as to minimizeresistance to movement of hollow push tubes 30 relative to support tubes50 (and hence minimize resistance to movement of hollow push tubes 30relative to sleeve 15). In this respect it should be appreciated thatminimizing resistance to the movement of hollow push tubes 30 relativeto support tubes 50 improves tactile feedback to the user when hollowpush tubes 30 are being used to manipulate fore balloon 35. In one formof the invention, support tubes 50 are flexible (so as to permitendoscope 10, and particularly the articulating portion of steerableendoscope 10, to flex as needed during the procedure); however, supporttubes 50 also provide some column strength. Thus, when support tubes 50are mounted within lumens 52 formed in sleeve 15, the assembly of sleeve15 and hollow support tubes 50 is flexible yet has a degree of columnstrength (whereas sleeve 15 alone is flexible but has substantially nocolumn strength). In the event that hollow push tubes 30 are containedwithin lumens 52 formed in sleeve 15, and in the event that supporttubes 50 are not disposed between hollow push tubes 30 and lumens 52,lumens 52 are preferably lubricated so as to minimize friction betweenhollow push tubes 30 and lumens 52.

The distal ends of the pair of hollow push tubes 30 are connectedtogether with a raised push tube bridge 31 (FIG. 7). Raised push tubebridge 31 provides a rounded structure at the distal ends of hollow pushtubes 30 which simultaneously serves to (i) connect the distal ends ofhollow push tubes 30 together, and (ii) eliminate abrupt ends at thedistal end of hollow push tubes 30 which could cause trauma to tissue,e.g., during distal advancement of hollow push tubes 30. Raised pushtube bridge 31 is configured to nest an endoscope therein (FIG. 8).

In one preferred form of the invention, raised push tube bridge 31 isalso hollow. In this form of the invention, the hollow raised push tubebridge 31 may be formed integral with hollow push tubes 30, i.e., thehollow push tubes 30 and the hollow raised push tube bridge 31 may formone continuous tube (FIGS. 9-11). Or, in this form of the invention, thehollow raised push tube bridge 31 may be formed separately from hollowpush tubes 30 and the hollow raised push tube bridge 31 may be joined tohollow push tubes 30 during manufacturing (FIG. 12).

In one preferred form of the invention, raised push tube bridge 31 maybe substantially solid and is connected with hollow push tubes 30 duringmanufacture.

If desired, raised push tube bridge 31 may be inclined distally, e.g.,in the manner shown in FIGS. 7-12.

Alternatively, if desired, raised push tube bridge 31 may be setsubstantially perpendicular to the longitudinal axes of hollow pushtubes 30, e.g., in the manner shown in FIG. 13.

Furthermore, if desired, raised push tube bridge 31 may be in the formof a ring, with endoscope 10 nesting within the interior of the ring,e.g., in the manner shown in FIG. 14.

The proximal ends of hollow push tubes 30 are connected to push tubehandle 37. As a result of this construction, pushing distally on pushtube handle 37 causes the distal ends of hollow push tubes 30 to movedistally (at the same rate) relative to sleeve 15 (whereby to move foreballoon 35 distally relative to aft balloon 20) and pulling proximallyon push tube handle 37 causes the distal ends of hollow push tubes 30 toretract proximally (at the same rate) relative to sleeve (whereby tomove fore balloon 35 proximally relative to aft balloon 20). Note thatby moving hollow push tubes 30 distally or proximally at the same rate,the distal ends of the hollow push tubes are maintained parallel to eachother. A clamp 53 (FIGS. 37 and 60) is provided at base 25 for holdinghollow push tubes in a selected disposition relative to base 25 (andhence in a selected disposition relative to sleeve 15).

Hollow push tubes 30 and raised push tube bridge 31 are preferablyformed out of a relatively flexible material which provides good columnstrength, e.g., a thermoplastic polyethylene resin such as Isoplast™(available from The Lubrizol Corporation of Wickliffe, Ohio),polyethylene, polypropylene, nylon, etc. It should be appreciated thathollow push tubes 30 and raised push tube bridge 31 can comprise asingle material or a plurality of materials, and that the stiffness ofhollow push tubes 30 and raised push tube bridge 31 can vary along theirlength. By way of example but not limitation, the distal-most portion ofhollow push tubes 30 and raised push tube bridge 31 can be formed of thesame material as the remainder of the hollow push tubes but have a lowermodulus so as to be more flexible than the remainder of the hollow pushtubes, or the distal-most portion of hollow push tubes 30 and raisedpush tube bridge 31 can comprise a different, more resilient flexiblematerial. By way of example but not limitation, the distal-most portionof hollow push tubes 30 and raised push tube bridge 31 can compriseNitinol. By way of further example but not limitation, the distal-mostportion of hollow push tubes 30 and raised push tube bridge 31 cancomprise a stainless steel coil covered with an outer jacket ofpolytetrafluoroethylene (PTFE), with the distal-mostjacket/more-proximal tubing together providing a sealed lumen forinflating/deflating fore balloon 35. By forming hollow push tubes 30 andraised push tube bridge 31 with distal ends which are more flexible thanthe remainder of the hollow push tubes, the hollow push tubes 30, raisedpush tube bridge 31 and fore balloon 35 can together function as a lead(with a soft atraumatic tip) for apparatus 5 and endoscope 10, asdiscussed further below.

In one preferred form of the invention, hollow push tubes 30 areconfigured to maintain a parallel disposition when they are in anunbiased state, i.e., when no force is being applied to hollow pushtubes 30. This is true regardless of the state of inflation or deflationof fore balloon 35. The provision of raised push tube bridge 31 can helpmaintain the parallel disposition of hollow push tubes 30.

The distal-most portion of hollow push tubes 30 can be configured tobend inwardly or outwardly if desired e.g., via their connection toraised push tube bridge 31. With such a configuration, when the distalends of hollow push tubes 30 are held longitudinally stationary (e.g.,by an inflated fore balloon, as will hereinafter be discussed) and asufficient distally-directed force is applied to hollow push tubes 30,the middle portions of hollow push tubes 30 (i.e., the portions betweenthe inflated fore balloon 35 and sleeve 15) can bend or bow outwardly,whereby to push outwardly on the side wall of the body lumen whichapparatus 5 is disposed in, thereby providing a “tenting” effect on theside wall of the body lumen and/or body cavity in the space between aftballoon 20 and fore balloon 35. This “tenting” effect can significantlyenhance visibility and/or tissue stability in the area distal toendoscope 10, by pushing outwardly on the side wall of the body lumenand/or body cavity in which apparatus 5 is disposed.

It should also be appreciated that by forming hollow push tubes 30 outof a flexible material, it is possible to manually adjust their positionduring use (e.g., by using a separate tool, by torqueing the apparatus,etc.) so as to prevent the hollow push tubes 30 from interfering withvisualization of the patient's anatomy and/or interfering withdiagnostic or therapeutic tools introduced into the space between thefore and aft balloons 35, 20. By way of example but not limitation, ifapparatus 5 is disposed in the anatomy in such a way that a hollow pushtube 30 blocks visual or physical access to a target region of theanatomy, the flexible hollow push tube(s) may be moved out of the way byusing a separate tool or instrument, or by rotating the apparatus with atorqueing motion so as to move the flexible hollow push tube(s) out ofthe way, etc. By way of further example but not limitation, byconstructing hollow push tubes 30 so that they are circular and flexibleand of a diameter significantly smaller than the round circumference ofendoscope 10, the movement of the round endoscope, when articulated, cansimply push the hollow push tubes out of the way and provides aunobstructed visual path to the tissue of interest.

It should also be appreciated that, if desired, hollow push tubes 30 canbe marked with an indicator including distance markers (not shown in thefigures), e.g., colored indicators or radiopaque indicators, so that aphysician (or other operator or user) observing the surgical site viaendoscope 10 or by radiological guidance (e.g., X-ray fluoroscopy) canascertain the relative disposition of hollow push tubes 30 at thesurgical site both longitudinally and/or circumferentially with respectto the side wall of the body lumen and/or other body cavity.

Hollow push tubes 30 have their internal lumens (i) in fluidcommunication with the interior of fore balloon 35 (FIGS. 1-5, 15 and16), e.g., via a plurality of openings 32, and (ii) in fluidcommunication with a fitting 56 mounted to base 25. Fitting 56 isconfigured for connection to the aforementioned associated inflationmechanism 40, in order that fore balloon 35 may be selectivelyinflated/deflated with air or other fluids (including liquids). Fitting56 is preferably a luer-activated valve, allowing inflation mechanism 40to be disconnected from fitting 56 without losing pressure in foreballoon 35.

More particularly, in one preferred form of the present invention, andlooking now at FIG. 17, push tube handle 37 comprises a hollow interior57. Hollow push tubes 30 are mounted to push tube handle 37 so thathollow push tubes 30 will move in conjunction with push tube handle 37,and so that the hollow interiors of hollow push tubes 30 are in fluidcommunication with the hollow interior 57 of push tube handle 37. Pushtube handle 37 also comprises a fitting 58 which is in fluidcommunication with hollow interior 57 of push tube handle 37. A flexibletube 59 connects fitting 58 with an internal chamber (not shown) in base25, with this internal chamber in base 25 being in fluid communicationwith the aforementioned fitting 56. As a result of this construction,when push tube handle 37 is moved distally, hollow push tubes 30 aremoved distally, and hence fore balloon 35 is moved distally; and whenpush tube handle 37 is moved proximally, hollow push tubes 30 are movedproximally, and hence fore balloon 35 is moved proximally. Furthermore,when positive fluid pressure is applied to fitting 56 in base 25,positive fluid pressure is applied to the internal lumens of hollow pushtubes 30, and hence to the interior of fore balloon 35 (i.e., viaopenings 32), whereby to inflate fore balloon 35; and when negativefluid pressure is applied to fitting 56 in base 25, negative fluidpressure is applied to the internal lumen of hollow push tubes 30, andhence to the interior of fore balloon 35 (i.e., via openings 32),whereby to deflate fore balloon 35.

It should be appreciated that the provision of a pair of hollow pushtubes 30, connected together at their distal ends by a raised push tubebridge 31, provides numerous advantages. By way of example but notlimitation, the provision of a pair of hollow push tubes 30, connectedtogether at their distal ends by a raised push tube bridge 31, providesa symmetric force to fore balloon 35 when the fore balloon is advanceddistally into a body lumen, as will hereinafter be discussed.Furthermore, the provision of a pair of hollow push tubes 30, connectedtogether at their distal ends by a raised push tube bridge 31, providesequal outward forces against the adjacent anatomy when the pair ofhollow push tubes are employed to straighten out the anatomy in the areaproximate the distal end of endoscope 10, thereby enhancingvisualization of, and/or access to, the anatomy, as will hereinafter bediscussed. In addition, the provision of a pair of hollow push tubes 30,connected together at their distal ends by a raised push tube bridge 31,ensures that fore balloon 35 remains centered on endoscope 10, therebyfacilitating un-docking of fore balloon 35 from endoscope 10 andre-docking of fore balloon 35 over endoscope 10, as will hereinafter bediscussed. In addition, the provision of a pair of hollow push tubes 30,connected together at their distal ends by a raised push tube bridge 31,helps ensure that fore balloon 35 is stable relative to the tip of theendoscope, minimizing rotational movement of the fore balloon wheninflated. Furthermore, the provision of a pair of hollow push tubes,connected together at their distal ends by a raised push tube bridge 31,provides a redundant air transfer system for inflating or deflating foreballoon 35. And the provision of a pair of hollow push tubes 30,connected together a their distal ends by a raised push tube bridge 31,presents a rounded, blunt distal end for hollow push tubes 30, therebyensuring atraumatic advancement of fore balloon 35 within the anatomy.

The Fore Balloon

Fore balloon 35 is secured to the distal ends of hollow push tubes 30,with raised push tube bridge 31 being disposed within the interior offore balloon 35, whereby the spacing between aft balloon 20 and foreballoon 35 can be adjusted by moving hollow push tubes 30 relative tosleeve 15, i.e., by moving push tube handle 37 relative to sleeve 15.Furthermore, hollow push tubes 30 provide a conduit between the interiorof fore balloon 35 and fitting 56, whereby to permit selectiveinflation/deflation of fore balloon 35 via fitting 56.

Significantly, fore balloon 35 is configured so that (i) when it isdeflated (or partially deflated) and it is in its “retracted” positionrelative to sleeve 15 (FIG. 2), fore balloon 35 provides an axialopening 63 (FIGS. 15, 16 and 19) sufficient to accommodate sleeve 15 andthe shaft of endoscope 10 therein, with raised push tube bridge 31extending concentrically about axial opening 63, whereby fore balloon 35can be “docked” over sleeve 15 and endoscope 10, and (ii) when foreballoon 35 is in its “extended” position relative to sleeve 15 and isappropriately inflated (FIG. 4), axial opening 63 is closed down (andpreferably completely closed off). At the same time, when appropriatelyinflated, the fore balloon can atraumatically engage and form a sealingrelationship with the side wall of a body lumen and/or body cavitywithin which apparatus 5 is disposed. Thus, when fore balloon 35 isappropriately inflated, the fore balloon can effectively seal the bodylumen and/or body cavity distal to fore balloon 35, by closing downaxial opening 63 and forming a sealing relationship with the side wallof the body lumen and/or body cavity within which apparatus 5 isdisposed. In this way, when hollow push tubes 30 are advanced distallyso as to separate fore balloon 35 from aft balloon 20, and when foreballoon 35 and aft balloon 20 are appropriately inflated, the twoballoons will create a sealed zone therebetween (sometimes hereinafterreferred to as “the therapeutic zone”).

It will be appreciated that, when fore balloon 35 is reconfigured fromits deflated condition to its inflated condition, fore balloon 35expands radially inwardly (so as to close down axial opening 63) as wellas radially outwardly (so as to engage the surrounding tissue). Notethat hollow push tubes 30 and raised push tube bridge 31 are disposedwithin fore balloon 35 in such a way that their presence within the foreballoon does not physically interfere with inflation or deflation offore balloon 35.

Thus it will be seen that fore balloon 35 has a “torus” shape whendeflated (to allow it to seat over the distal end of the endoscope) anda substantially “solid” shape when inflated (to allow it to close off abody lumen or body cavity).

To this end, and looking now at FIGS. 18 and 19, fore balloon 35 ispreferably manufactured as a single construct comprising a body 67having a proximal opening 69 and a distal opening 71, a proximalextension 73 having a “key-shaped” cross-section comprising lobes 74,and a distal extension 76 having a circular cross-section. Note thatlobes 74 are disposed on proximal extension 73 with a configurationwhich matches the configuration of hollow push tubes 30 (i.e., whereapparatus 5 comprises two hollow push tubes 30 diametrically opposed toone another, proximal extension 73 will comprise two lobes 74diametrically opposed to one another—for the purposes of the presentinvention, proximal extension 73 and lobe(s) 74 may be collectivelyreferred to as having a “key-shaped” cross-section). During assembly,proximal extension 73 is everted into the interior of body 67, hollowpush tubes 30 are seated in lobes 74 of proximal extension 73, (with theinteriors of hollow push tubes 30 being in fluid communication with theinterior of body 67 and with raised push tube bridge 31 disposed withinthe interior of body 67), and then distal extension 76 is everted intothe interior of proximal extension 73, whereby to provide a fore balloon35 having axial opening 63 extending therethrough, with hollow pushtubes 30 being secured to fore balloon 35 and communicating with theinterior of fore balloon 35, and with raised push tube bridge 31 beingdisposed concentrically about axial opening 63. Significantly, axialopening 63 is sized to receive the distal end of endoscope 10 therein,and raised push tube bridge 31 is sized to nest endoscope 10 in the areabeneath the raised push tube bridge 31. Also significantly, theformation of fore balloon 35 by the aforementioned process of evertingproximal extension 73 into the interior of body 67, and then evertingdistal extension 76 into the interior of proximal extension 73, providesmultiple layers of balloon material around hollow push tubes 30, therebyproviding a more robust balloon construction. Among other things,providing multiple layers of balloon material around hollow push tubes30 adds cushioning to the distal ends of hollow push tubes 30, therebyproviding an even more atraumatic distal tip to hollow push tubes 30 andfurther ensuring that the distal tips of hollow push tubes 30 do notdamage the adjacent tissue.

In one preferred form of the invention, fore balloon 35 is formed out ofpolyurethane.

It should be appreciated that when fore balloon 35 is in its deflatedcondition, the material of fore balloon 35 substantially encompasses thedistal ends of hollow push tubes 30 and raised push tube bridge 31(while still allowing hollow push tubes 30 to be in fluid communicationwith the interior of fore balloon 35, i.e., via openings 32), therebyproviding an atraumatic tip for advancing fore balloon 35 distallythrough a body lumen. Furthermore, hollow push tubes 30, raised pushtube bridge 31 and the deflated fore balloon 35 can, together,essentially function as a soft-tipped lead for apparatus 5 and endoscope10, as discussed further below (FIG. 93).

If desired, one or both of aft balloon 20 and fore balloon 35 can bemarked with an indicator (e.g., a color indicator or a radiopaqueindicator) so that a physician (or other operator or user) observing thesurgical site via endoscope 10 or radiological guidance (e.g., X-rayfluoroscopy) can ascertain the disposition of one or both of theballoons at the surgical site.

Alternative Construction for the Base and the Push Tube Handle

As noted above, and as shown in FIG. 1, apparatus 5 comprises a base 25which is secured to sleeve 15 at the proximal end of the sleeve andwhich carries fittings 46, 56 for inflating/deflating aft balloon 20and/or fore balloon 35, respectively. Apparatus 5 also comprises a pushtube handle 37 which has hollow push tubes 30 mounted thereto, withhollow push tubes 30 physically supporting (and providing fluidcommunication to) the interior of fore balloon 35. As also noted above,proximal inflation/deflation tube 45 provides fluid communicationbetween fitting 46 of base 25 and the interior of aft balloon 20; and aflexible tube 59 provides (with other elements) fluid communicationbetween fitting 56 of base 25 and the interior of hollow push tubes 30(and hence the interior of fore balloon 35).

With the construction shown in FIG. 1, base 25 supports and guideshollow push tubes 30 as they are advanced distally or retractedproximally, but base 25 does not directly support and guide push tubehandle 37 as it is advanced distally or retracted proximally.

To that end, if desired, and looking now at FIGS. 20-25, apparatus 5 maycomprise a similar but somewhat different base (i.e., the base 25A) anda similar but somewhat different push tube handle (i.e., the push tubehandle 37A). Base 25A comprises an extension 205 which has theaforementioned fittings 46, 56 mounted thereto. Extension 205 comprisesa center slot 210 and a pair of side slots 215. Push tube handle 37Acomprises a C-shaped body 220 having hollow push tubes 30 mountedthereto, and having a center locking element 225 and a pair of fingergrips 230 mounted thereto. Locking element 225 preferably comprises ascrew shaft 235 and a screw knob 240, such that screw knob 240 can beadvanced towards or away from body 220 by turning the screw knob.

Push tube handle 37A is mounted within extension 205 of base 25A so thatscrew shaft 235 is slidably received in center slot 210 and so thatfinger grips 230 are slidably received in side slots 215, whereby toprovide support and guidance to push tube handle 37A.

As a result of this construction, push tube handle 37A can be moveddistally or proximally by moving screw shaft 235 and finger grips 230distally or proximally, whereby to move fore balloon 35 distally orproximally; and push tube handle 37A can be locked in position relativeto body 25A by turning screw knob 240 so that it securely engages theouter surface of extension 205, whereby to lock fore balloon 35 inposition relative to body 25A. Note that torsion can be applied to foreballoon 35 by applying torsion to finger grips 230, e.g., by moving oneside wing 230 distally while pulling the other side wing 230 proximally.

FIGS. 26-30 show different configurations for screw knob 240.

If desired, lubricious washers 245 may be added to the assembly toreduce friction (FIG. 31), or texture may be added to surfaces (e.g.,the underside of screw knob 240 as shown in FIG. 32) so as to increasefriction. Furthermore, finger grips 230 may be shaped differently thanthose illustrated in FIGS. 20-30, or moved to a different portion of theassembly. See, for example, FIG. 33, which shows finger grips 230 formedas part of a second knob 250 which keys to the slider assembly.

It should also be appreciated that, if desired, push tube handle 37A maycomprise a generally C-shaped body having a different configuration fromthe C-shaped body 220 shown in FIGS. 23, 25, 31 and 33. By way ofexample but not limitation, and looking now at FIG. 34, C-shaped body220 may comprise a pair of downwardly extending legs 255 connected by alinkage 260.

The Inflation Mechanism

Inflation mechanism 40 provides a means to selectively inflate aftballoon 20 and/or fore balloon 35.

In one preferred form of the present invention, and looking now at FIGS.1 and 35, inflation mechanism 40 comprises a single-line syringeinserter 140 comprising a body 145 and a plunger 150. Preferably aspring 153 is provided in body 145 to automatically return plunger 150at the end of its stroke. Syringe inserter 140 is connected to one orthe other of fittings 46, 56 via a line 155. Thus, with thisconstruction, when single-line syringe inserter 140 is to be used toinflate aft balloon 20, syringe inserter 140 is connected to fitting 46via line 155 so that the output of single-line syringe inserter 140 isdirected to aft balloon 20 (i.e., via proximal inflation/deflation tube45). Correspondingly, when single-line syringe inserter 140 is to beused to inflate fore balloon 35, syringe inserter 140 is connected tofitting 56 via line 155 so that the output of single-line syringeinserter 140 is directed to fore balloon 35 (i.e., via flexible tube 59and the interiors of hollow push tubes 30 and out of openings 32).

In another preferred form of the present invention, and looking now atFIG. 36, inflation mechanism 40 comprises an elastic bulb 156 having afirst port 157 and a second port 158. A one-way valve 159 (e.g., a checkvalve) is disposed in first port 157 so that air can only pass throughfirst port 157 when traveling in an outward direction. Another one-wayvalve 159 (e.g., a check valve) is disposed in second port 158 so thatair can only pass through second port 158 when traveling in an inwarddirection. When elastic bulb 156 is compressed (e.g., by hand), airwithin the interior of elastic bulb 156 is forced out first port 157;and when elastic bulb 156 is thereafter released, air is drawn back intothe interior of elastic bulb 156 through second port 158.

As a result of this construction, when elastic bulb 156 is to be used toinflate aft balloon 20, first port 157 is connected to fitting 46 vialine 155 so that the positive pressure output of elastic bulb 156 isdirected to aft balloon 20. Elastic bulb 156 may thereafter be used todeflate aft balloon 20, i.e., by connecting second port 158 to fitting46 via line 155 so that the suction of elastic bulb 156 is directed toaft balloon 20. Correspondingly, when elastic bulb 156 is to be used toinflate fore balloon 35, first port 157 is connected to fitting 56 vialine 155 so that the positive pressure output of elastic bulb 156 isdirected to fore balloon 35. Elastic bulb 156 may thereafter be used todeflate fore balloon 35, i.e., by connecting second port 158 to fitting56 via line 155 so that the suction of elastic bulb 156 is directed tofore balloon 35.

Alternatively, and looking now at FIGS. 37 and 38, a syringe 160 may beused to inflate aft balloon 20 and/or fore balloon 35. Inflationmechanism 160 comprises a body 161 and a plunger 162. Preferably aspring (not shown) is provided in body 161 to automatically returnplunger 162 at the end of its power stroke. Syringe 160 is connected tofittings 46, 56 via a line 163. With this construction, syringe 160comprises a valve 165 for connecting syringe 160 to fore balloon 35 oraft balloon 20, and a valve 170 for selecting inflation or deflation ofthe connected-to balloon.

Thus, with this construction, when syringe 160 is to be used to inflateaft balloon 20, valve 165 (a two-position valve that connects valve 170to either the fore balloon or the aft balloon) is set so that thesyringe 160 is connected through fitting 46 to aft balloon 20, and valve170 (a 2-way crossover valve which allows the one-way valves to bearranged to inflate in one configuration and deflate in the otherconfiguration) is set so that syringe 160 is providing inflationpressure. Thereafter, when aft balloon 20 is to be deflated, valve 170is set to its deflate position.

Correspondingly, when syringe 160 is to be used to inflate fore balloon35, valve 165 is set so that syringe 160 is connected through fitting 56to fore balloon 35, and valve 170 is set so that syringe 160 isproviding inflation pressure. Thereafter, when fore balloon 35 is to bedeflated, valve 170 is set to its deflate position.

In another preferred form of the present invention, and looking now atFIGS. 39-58, inflation mechanism 40 comprises a hand inflator 300 alsoformed in accordance with the present invention. Hand inflator 300generally comprises a housing 305 carrying a bulb or “pump” 310, an aftballoon inflation line 315 (for connection to fitting 46 of apparatus 5,see FIG. 1), a fore balloon inflation line 320 (for connection tofitting 56 of apparatus 5, see FIG. 1), and internal pneumatic apparatus325 (FIG. 42) for directing air between pump 310 and aft ballooninflation line 315 and fore balloon inflation line 320 (and for ventingair from aft balloon inflation line 315 and fore balloon inflation line320), all as will hereinafter be discussed.

As seen in FIGS. 42 and 43, internal pneumatic apparatus 325 comprises acheck valve 330, a check valve 335, a check valve 340, a multi-way valve345, a fore balloon indicator 350, an aft balloon indicator 355, a checkvalve 360, a check valve 365, an “air in” port 367 and an “air out” port368. A selector knob 370 (FIGS. 39, 40 and 41) is attached to multi-wayvalve 345 so as to allow the user to set multi-way valve 345 as desired,and openings 375, 380 (FIG. 40) are formed in housing 305 so as toexpose fore balloon indicator 350 and aft balloon indicator 355,respectively, to the view of the user.

Looking now at FIGS. 44 through 47, internal pneumatic apparatus 325 isconfigured so that (i) aft balloon 20 can be selectively inflated bypump 310, (ii) aft balloon 20 can be selectively deflated by pump 310,(iii) fore balloon 35 can be selectively inflated by pump 310, and (iv)fore balloon 35 can be selectively deflated by pump 310.

More particularly, when aft balloon 20 is to be inflated, and lookingnow at FIG. 44, selector knob 370 is set so that multi-way valve 345creates a fluid line connecting “air in” port 367, check valve 340,check valve 335, pump 310, check valve 330, aft balloon indicator 355,check valve 365, aft balloon inflation line 315 and aft balloon 20, sothat repeated compressions of pump 310 inflates aft balloon 20, with thepressure within aft balloon 20 being indicated by aft balloon indicator355.

When aft balloon 20 is to be deflated, and looking now at FIG. 45,selector knob 370 is set so that multi-way valve 345 creates a fluidline connecting aft balloon 20, aft balloon inflation line 315, checkvalve 365, aft balloon indicator 355, check valve 340, check valve 335,pump 310, check valve 330 and “air out” port 368, so that repeatedcompressions of pump 310 deflates aft balloon 20, with the pressurewithin aft balloon 20 being indicated by aft balloon indicator 355.

When fore balloon 35 is to be inflated, and looking now at FIG. 46,selector knob 370 is set so that multi-way valve 345 creates a fluidline connecting “air in” port 367, check valve 340, check valve 335,pump 310, check valve 330, fore balloon indicator 350, check valve 360,fore balloon inflation line 320 and fore balloon 35, so that repeatedcompressions of pump 310 inflates fore balloon 35, with the pressurewithin fore balloon 35 being indicated by fore balloon indicator 350.

When fore balloon 35 is to be deflated, and looking now at FIG. 47,selector knob 370 is set so that multi-way valve 345 creates a fluidline connecting fore balloon 35, fore balloon inflation line 320, checkvalve 360, fore balloon indicator 350, check valve 340, check valve 335,pump 310, check valve 330 and “air out” port 368, so that repeatedcompressions of pump 310 deflates fore balloon 35, with the pressurewithin fore balloon 35 being indicated by fore balloon indicator 350.

In one preferred form of the invention, and looking now at FIGS. 48 and13K, fore balloon indicator 350 and aft balloon indicator 355 eachcomprise a piston 385. Piston 385 is created by attaching two end caps390, 395 together with a pliable extrusion 400. End cap 390 is securelymounted to housing 305 and is pneumatically connected by a tube 405 tothe system pressure which is to be measured (i.e., to a balloon, eitherthe fore balloon 35 or the aft balloon 20, depending on whether piston385 is employed in fore balloon indicator 350 or aft balloon indicator355). End cap 395 rides along tube 405 and abuts a spring 410 whichengages a wall 415 of housing 305. End cap 395 includes an alignmentfeature 420 which is slidably disposed in a guide (not shown) in housing305, and a color pressure indicator 425 which is visible through one orthe other of the aforementioned openings 375, 380 (depending on whetherpiston 385 is employed in fore balloon indicator 350 or aft balloonindicator 355). End cap 395 acts as the pressure indicator, inasmuch asthe longitudinal position of second end cap 395 along tube 405 (relativeto wall 415) is an indicator of system pressure. In essence, the two endcaps 390, 395 and extrusion 400 effectively constitute a piston (i.e.,piston 385) which expands and contracts as the system pressure changes,with system pressure being reflected by the disposition of colorpressure indicator 425 relative to one or the other of theaforementioned openings 375, 380.

When there is no pressure in the system (i.e., when the fore balloon orthe aft balloon is entirely deflated), the indicator remains in theposition shown in FIG. 50. In this position, extrusion 400 is collapsedand folded upon itself. When pressure is introduced into the system (andhence, into tube 405) and a balloon (i.e., fore balloon 35 or aftballoon 20) begins to inflate, end cap 395 begins to move relative totube 405, compressing spring 410. The distance that end cap 395 movesdepends on the pressure in the system (i.e., the pressure within tube405), the diameter of the extrusion, and the bias force of the spring.FIG. 51 shows piston 385 and extrusion 400 fully extended (i.e.,indicating maximum pressure within the system or, to put it another way,complete inflation of either fore balloon 35 or aft balloon 20).Ideally, the fully-extended position of color pressure indicator 425relative to openings 375, 380 in housing 305 correlates to the maximumallowable pressure of fore balloon 35 or aft balloon 20.

It should be appreciated that since the position of a color pressureindicator 425 relative to an opening 375, 380 in housing 305 isreflective of the pressure within the system (i.e., the pressure withineither fore balloon 35 or aft balloon 20), in one preferred form of thepresent invention, various colors (e.g., green, yellow and red) are usedto correspond to various predetermined pressures within the system.

Thus, the design shown in FIGS. 48-53 comprises a colored indicator(i.e., color pressure indicator 425) attached to the “dynamic” (i.e.,moving) end cap 395 of piston 385. The color scheme on each indicatoralerts the user as to how “full” (i.e., how inflated) each of theballoons (i.e., fore balloon 35 or aft balloon 20) is. However, itshould also be appreciated that, if desired, the indicator couldcomprise numeric pressure values instead of colors. Alternatively, thepressure level could be indicated by a strip of colors (or numbers)fixed to the housing (i.e., adjacent openings 375, 380 in housing 305).In this form of the invention, the end cap 395 comprises a pointer whichextends out of opening 375 or 380 and, as the piston expands (i.e., aspliable extrusion 400 expands and end cap 395 moves toward wall 415against the power of spring 410) and contracts (i.e., as pliableextrusion 400 contracts and end cap 395 moves away from wall 415 underthe power of spring 410), the pointer points to the appropriate pressureindication mark on housing 305.

The design shown in FIGS. 48-53 illustrates the two end caps 390, 395 ofpiston 385 being separated by a tubular pliable extrusion 400. However,it should also be appreciated that, if desired, pliable extrusion 400may be replaced by a balloon 430 (FIG. 54). Balloon 430 is preferablyspherical (FIG. 54), although it may also comprise other shapes ifdesired (see, for example, FIG. 55, which shows a generallydiamond-shaped balloon 430, and FIG. 56 which shows a generally tubularballoon 430). Or, if desired, balloon 430 may be used to push a flagupward, i.e., perpendicular to the axis of the balloon, instead ofexpanding a piston along its axis. See FIGS. 57 and 58.

In yet another form of the invention, inflation mechanism 40 maycomprise an automated source of fluid pressure (either positive ornegative), e.g., an electric pump.

If desired, and looking now at FIG. 59, a relief valve 175 can beconnected to the inflation/deflation line which connects to fore balloon35 so as to ensure that the pressure within fore balloon 35 does notexceed a predetermined level. Similarly, and still looking now at FIG.59, a relief valve 180 can be connected to the inflation/deflation linewhich connects to aft balloon 20 so as to ensure that the pressurewithin aft balloon 20 does not exceed a predetermined level.

Alternatively, and/or additionally, one or more pressure gauges 182(FIG. 1 or FIG. 38) may be incorporated into the fluid line connected toaft balloon 20, and/or the fluid line connected to fore balloon 35,whereby to provide the physician (or other operator or user) withinformation relating to the pressure inside aft balloon 20 and/or foreballoon 35 so as to avoid over inflation and/or to help the physician(or other operator or user) ascertain the inflation state of a balloonduring a procedure.

Furthermore, it will be appreciated that as fore balloon 35 movesbetween its “retracted” position (FIG. 2) and its “extended” position(FIG. 4), the flexible tube 59 connecting push tubes 30 to base 25 (andhence to fitting 56) may gather about base 25, potentially interferingwith the physician's (or other operator's or user's) actions.Accordingly, if desired, and looking now at FIG. 60, a flexible tuberetraction system 185 may be provided (e.g., within base 25) to take upslack in flexible tube 59 when fore balloon 35 is extended.

Hand Inflator Incorporating a Novel Manifold

As discussed above, in one preferred form of the invention, inflationmechanism 40 comprises a hand inflator 300 (FIGS. 39-58) for selectivelyinflating/deflating a selected one of fore balloon 35 and aft balloon20. Hand inflator 300 generally comprises a manual pump (e.g., bulb 310)for providing an air pressure/suction source, and a multi-way valve 345for directing the flow of air from/to bulb 310 to/from a selected one offore balloon 35 and aft balloon 20.

In one form of the present invention, and looking first at FIGS. 61 and62, multi-way valve 345 preferably takes the form of a novel manifold500 disposed within housing 305 of hand inflator 300. Manifold 500generally comprises a bottom plate 505 fluidically connected to bulb310, a rotatable middle plate 510, and a top plate 515 fluidicallyconnected to fore balloon 35, aft balloon 20, fore balloon indicator 350and aft balloon indicator 355. A shaft 520 passes through, and connectstogether, top plate 515, middle plate 510 and bottom plate 505, as willhereinafter be discussed in further detail. Looking next at FIG. 63,bottom plate 505 generally comprises a body 525 having a cavity 530formed therein. Bottom plate 505 also comprises an inflation port 535configured to be fluidically connected to an air pressure source (e.g.,bulb 310) and a deflation port 540 configured to be fluidicallyconnected to an air suction source (e.g., bulb 310). Inflation port 535and deflation port 540 are fluidically connected to cavity 530, as willhereinafter be discussed in further detail.

Cavity 530 of bottom plate 505 comprises (i) a central opening 545 whichpasses through body 525 of bottom plate 505 for rotatably receivingshaft 520 therein, and (ii) a plurality of O-rings 550 which aredisposed in cavity 530 and arranged concentrically about central opening545. O-rings 550 define two ring-shaped zones which are disposedcoaxially relative to one another and which can be fluidically isolatedfrom one another (i.e., when middle plate 510 is mounted on top ofbottom plate 505 and covers cavity 530, as will hereinafter bediscussed). More particularly, O-rings 550 define an inner deflationzone 555 and an outer inflation zone 560 disposed coaxially about innerdeflation zone 555. Inner deflation zone 555 comprises an opening 565which is fluidically connected to deflation port 540, and outerinflation zone 560 comprises an opening 570 which is fluidicallyconnected to inflation port 535. In one preferred form of the invention,bottom plate 505 also comprises a check valve 575 fluidically connectedto deflation port 540 for allowing bulb 310 to “re-form” (i.e., draw airthrough check valve 575) when it is not possible to draw air fromatmosphere through inner deflation zone 555 (it will be appreciated thatcheck valve 575 is functionally equivalent to the check valve 340 shownin FIG. 65).

Looking next at FIG. 64, middle plate 510 comprises a body 580 having asmooth bottom surface 585 for sealingly engaging O-rings 550 disposed incavity 530 of bottom plate 505 (whereby to fluidically seal innerdeflation zone 555 and outer inflation zone 560), and a smooth topsurface 590 for sealingly engaging top plate 515, as will hereinafter bediscussed in further detail. Body 580 of middle plate 510 comprises acentral opening 595 which passes through body 580 of middle plate 510and is configured to engage shaft 520 (e.g., central opening 595 maycomprise a non-circular cross-section which mates with a portion ofshaft 520 having a corresponding non-circular cross-section) such thatrotation of shaft 520 causes corresponding rotation of middle plate 510.Middle plate 510 also comprises an inner hole 600 and an outer hole 605which are disposed on a common radius and which pass through body 580 ofmiddle plate 510. Inner hole 600 is disposed so as to be in common orbitwith, and fluidically connected to, inner deflation zone 555 of bottomplate 505 when middle plate 510 is mounted over bottom plate 505. Outerhole 605 is disposed so as to be in common orbit with, and fluidicallyconnected to, outer inflation zone 560 of bottom plate 505 when middleplate 510 is mounted over bottom plate 505.

Looking next at FIGS. 65-67, top plate 515 comprises a body 610 having abottom surface 615, a top surface 620 and a central opening 625 passingthrough body 610 for rotatably receiving shaft 520. Top plate 515 alsocomprises an aft balloon connection port 630 for fluidically connectingaft balloon 20 to manifold 500, an aft balloon indicator port 635 forfluidically connecting aft balloon indicator 355 to manifold 500, an aftballoon channel 640 extending between aft balloon connection port 630and aft balloon indicator port 635, a fore balloon connection port 645for fluidically connecting fore balloon 35 to manifold 500, a foreballoon indicator port 650 for fluidically connecting fore balloonindicator 350 to manifold 500 and a fore balloon channel 655 extendingbetween fore balloon connection port 645 and fore balloon indicator port650.

Bottom surface 615 of body 610 comprises an aft balloon inflation port660 and an aft balloon deflation port 665 which open on bottom surface615 and which are fluidically connected to aft balloon channel 640.Bottom surface 615 of body 610 also comprises a fore balloon inflationport 670 and a fore balloon deflation port 675 which open on bottomsurface 615 and which are fluidically connected to fore balloon channel655. A plurality of O-rings 680 are disposed about ports 660, 665, 670,675 for effecting sealing engagement of ports 660, 665, 670, 675 withtop surface 590 of middle plate 510 as will hereinafter be discussed infurther detail. In one preferred form of the present invention, bottomsurface 615 of body 610 also comprises a balance O-ring 685 for helpingto maintain sealing engagement of O-rings 680 with top surface 590 ofmiddle plate 510, as will hereinafter be discussed in further detail.

In one preferred form of the invention, top plate 515 also comprises anaft balloon channel check valve 690 disposed in top plate 515 (it willbe appreciated that check valve 690 is functionally equivalent to thecheck valve 365 shown in FIG. 65). Aft balloon check valve 690 is influid communication with aft balloon channel 640 and preventsover-inflation of aft balloon 20 by releasing air to atmosphere when theair pressure within aft balloon channel 640 (which is the same as theair pressure within aft balloon 20) exceeds a predetermined threshold.In one preferred form of the invention, top plate 515 also comprises afore balloon channel check valve 695 disposed in top plate 515 (it willbe appreciated that check valve 695 is functionally equivalent to thecheck valve 360 shown in FIG. 43). Fore balloon check channel valve 695is in fluid communication with fore balloon channel 655 and preventsover-inflation of fore balloon 35 by releasing air to atmosphere whenthe air pressure within fore balloon channel 655 (which is the same asthe air pressure within fore balloon 35) exceeds a predeterminedthreshold.

Assembly of the Novel Manifold

Looking next at FIGS. 68 and 69, manifold 500 is assembled such thatmiddle plate 510 is rotatably disposed between bottom plate 505 and topplate 515, with shaft 520 passing through central opening 625 of topplate 515, through central opening 595 of middle plate 510 and throughcentral opening 545 of bottom plate 505. More particularly, the distalend of shaft 520 comprises a distal bearing 700 which is secured toshaft 520 by a retainer clip 705. The proximal end of shaft 520comprises a proximal bearing 710 which is secured to the proximal end ofshaft 520, with a spring 715 being disposed between proximal bearing 710and top surface 620 of top plate 515. A selector knob 720 is fixedlymounted to the proximal end of shaft 520 such that rotation of selectorknob 720 causes corresponding rotation of shaft 520 (and hencecorresponding rotation of middle plate 510). Shaft 520 is able to rotatefreely within central opening 625 of top plate 515 and central opening545 of bottom plate 505, and to also rotate freely within proximalbearing 710 and distal bearing 700. However, shaft 520 engages centralopening 595 of middle plate 510 such that rotation of shaft 520 causescorresponding rotation of middle plate 510, whereby to permit a user toselectively rotate middle plate 510 (i.e., by rotating selector knob720, which, in turn, rotates middle plate 510).

It will be appreciated that when the various components are assembled onshaft 520, bottom plate 505, middle plate 510 and top plate 515 are“sandwiched” between distal bearing 700 and proximal bearing 710 undercompression provided by spring 715, whereby to maintain constant contact(i) between bottom surface 585 of middle plate 510 and O-rings 550 ofbottom plate 505, (ii) between top surface 590 of middle plate 510 andO-rings 680 of top plate 515 (i.e., between top surface 590 of middleplate 510 and aft balloon inflation port 660, aft balloon deflation port665, fore balloon inflation port 670 and fore balloon deflation port675), and (iii) between top surface 590 of middle plate 510 and balanceO-ring 685 of top plate 515.

As a result, an air-tight air pathway is maintained through manifold 500between a selected one of (i) inflation port 535 or deflation port 540,and (ii) a selected one of fore balloon 35 or aft balloon 20, such thatbulb 310 may be used to selectively inflate or deflate a selected one offore balloon 35 or aft balloon 20, as will hereinafter be discussed infurther detail.

More particularly, it will be appreciated that rotating selector knob720 causes shaft 520 to rotate, thereby causing middle plate 510 torotate. When this occurs, inner hole 600 and outer hole 605 of middleplate 510 also rotate relative to bottom plate 505 and top plate 515.Since inner hole 600 of middle plate 510 is aligned in common orbit withinner deflation zone 555 of bottom plate 505, inner hole 600 is alwaysaligned with inner deflation zone 555, regardless of the rotationalposition of middle plate 510 (and hence, inner hole 600 is alwaysfluidically connected to deflation port 540, i.e., vis-à-vis opening 565in inner deflation zone 555). Similarly, since outer hole 605 of middleplate 510 is aligned in common orbit with outer inflation zone 560 ofbottom plate 505, outer hole 605 is always aligned with outer inflationzone 560 (and hence, outer hole 605 is always fluidically connected toinflation port 535 vis-à-vis opening 570 in outer inflation zone 560).

It will also be appreciated that when middle plate 510 is rotated (i.e.,by rotating selector knob 720), inner hole 600 of middle plate 510 maybe positioned so that it is (i) aligned with aft balloon deflation port665, or (ii) aligned with fore balloon deflation port 675, or (iii)unaligned with a port 665, 675 (and hence open to atmosphere).Similarly, outer hole 605 of middle plate 510 may be positioned so thatit is (i) aligned with aft balloon inflation port 660, or (ii) alignedwith fore balloon inflation port 670, or (iii) unaligned with a port660, 670 (and hence open to atmosphere). In this respect it will beappreciated that the provision of O-rings 680 and balance O-ring 685creates a small gap between bottom surface 615 of top plate 515 and topsurface 590 of middle plate 510, such that when either (or both) ofinner hole 600 and/or outer hole 605 of middle plate 510 are unalignedwith a port 665, 675, 660, 670, inner hole 600 and/or outer hole 605 areconnected with atmosphere.

As a result of this construction, it will be appreciated that middleplate 510 can be selectively rotated so as to occupy one of five states:(1) an aft balloon inflation state, wherein outer hole 605 of middleplate 510 is aligned with aft balloon inflation port 660 of top plate515 and inner hole 600 of middle plate 510 is open to atmosphere (“State1”); (2) an aft balloon deflation state wherein outer hole 605 of middleplate 510 is open to atmosphere and inner hole 600 of middle plate 510is aligned with aft balloon deflation port 665 of top plate 515 (“State2”); (3) a fore balloon inflation state wherein outer hole 605 of middleplate 510 is aligned with fore balloon inflation port 670 of top plate515 and inner hole 600 of middle plate 510 is open to atmosphere (“State3”); (4) a fore balloon deflation state wherein outer hole 605 of middleplate 510 is open to atmosphere and inner hole 600 of middle plate 510is aligned with fore balloon deflation port 675 (“State 4”); or (5) aninactive state wherein neither outer hole 605 nor inner hole 600 ofmiddle plate 510 is aligned with a port 660, 665, 670, 675 in top plate515, i.e., wherein both outer hole 605 and inner hole 600 are open toatmosphere and with ports 660, 665, 670, 675 of top plate 515 beingfluidically sealed against top surface 590 of middle plate 510 (“State5”).

Thus it will be seen that the relative positions of aft ballooninflation port 660, aft balloon deflation port 665, fore ballooninflation port 670 and fore balloon deflation port 675 within bottomsurface 615 of top plate 515 can be arranged such that rotation ofmiddle plate 510 causes selective switching between the States 1, 2, 3,4 and 5 discussed above.

By way of example but not limitation, in one preferred form of thepresent invention, State 1 is effected when knob 720 is in the “8o'clock” position, State 2 is effected when knob 720 is in the “4o'clock” position, State 3 is effected when knob 720 is in the “10o'clock” position, and State 4 is effected when knob 720 is in the “2o'clock” position. In this form of the invention, State 5 is effectedwhenever knob 720 is rotated to a position intermediate theaforementioned positions.

1. Aft Balloon Inflation.

Looking now at FIGS. 70-72, there is shown the path that air travelsthrough manifold 500 when middle plate 510 is in State 1 discussed abovefor effecting aft balloon inflation (i.e., when middle plate 510 isrotated such that outer hole 605 of middle plate 510 is aligned with aftballoon inflation port 660 of top plate 515 and inner hole 600 of middleplate 510 is open to atmosphere). In State 1, when bulb 310 is squeezedand released, free air from atmosphere is drawn into inner hole 600 ofmiddle plate 510, passes into inner deflation zone 555 of bottom plate505, through opening 565 in inner deflation zone 565, through deflationport 540, into bulb 310 and then back out of bulb 310, into inflationport 535, through opening 570, into outer inflation zone 560, throughouter hole 605 of middle plate 510, into aft balloon inflation port 660,through aft balloon channel 640, out of aft balloon connection port 630and into aft balloon 20. It should be appreciated that as this occurs,and looking now at FIG. 72, aft balloon deflation port 665, fore ballooninflation port 670 and fore balloon deflation port 675 are allfluidically sealed against top surface 590 of middle plate 510 so thatair cannot enter or leave via ports 665, 670, 675, and hence, whenmanifold 500 is in State 1, inflation of aft balloon 20 does not haveany effect on fore balloon 35.

2. Aft Balloon Deflation.

Looking next at FIGS. 73 and 74, there is shown the path that airtravels through manifold 500 when middle plate 510 is in State 2discussed above for effecting aft balloon deflation (i.e., when middleplate 510 is rotated such that outer hole 605 of middle plate 510 isopen to atmosphere and inner hole 600 of middle plate 510 is alignedwith aft balloon deflation port 665). In State 2, when bulb 310 issqueezed and released, air from aft balloon 20 is drawn into aft balloonconnection port 630, through aft balloon channel 640, out aft balloondeflation port 665, through inner hole 600 of middle plate 510, intoinner deflation zone 555, through opening 565, out deflation port 540,into bulb 310, back out of bulb 310, into inflation port 535, throughopening 570 in outer inflation zone 560, into outer inflation zone 560,through outer hole 605 of middle plate 510 and out to atmosphere. Itshould be appreciated that as this occurs, aft balloon inflation port660, fore balloon inflation port 670 and fore balloon deflation port 675are all fluidically sealed against top surface 620 of middle plate 510so that air cannot enter or leave via ports 660, 670, 675, and hence,when manifold 500 is in State 2, deflation of aft balloon 20 does nothave any effect on fore balloon 35.

3. Fore Balloon Inflation.

Looking next at FIGS. 75 and 76, there is shown the path that airtravels through manifold 500 when middle plate 510 is in State 3discussed above for effecting fore balloon inflation (i.e., when middleplate 510 is rotated such that outer hole 605 of middle plate 510 isaligned with fore balloon inflation port 670 of top plate 515 and innerhole 600 of middle plate 510 is open to atmosphere). In State 3, whenbulb 310 is squeezed and released, free air from atmosphere is drawninto inner hole 600 of middle plate 510, passes into inner deflationzone 555 of bottom plate 505, through opening 565 in inner deflationzone 565, through deflation port 540, into bulb 310 and then back out ofbulb 310, into inflation port 535, through opening 570, into outerinflation zone 560, through outer hole 605 of middle plate 510, intofore balloon inflation port 670, through fore balloon channel 655, outof fore balloon connection port 645 and into fore balloon 35. It shouldbe appreciated that as this occurs, aft balloon deflation port 665, aftballoon inflation port 660 and fore balloon deflation port 675 are allfluidically sealed against top surface 590 of middle plate 510 so thatair cannot enter or leave via ports 665, 660, 675, and hence, whenmanifold 500 is in State 3, inflation of fore balloon 35 does not haveany effect on aft balloon 20.

4. Fore Balloon Deflation.

Looking next at FIGS. 77 and 78, there is shown the path that airtravels through manifold 500 when middle plate 510 is in State 4discussed above for effecting fore balloon deflation (i.e., when middleplate 510 is rotated such that outer hole 605 of middle plate 510 isopen to atmosphere and inner hole 600 of middle plate 510 is alignedwith fore balloon deflation port 675). In State 4, when bulb 310 issqueezed and released, air from fore balloon 35 is drawn into foreballoon connection port 645, through fore balloon channel 655, throughfore balloon deflation port 675, through inner hole 600 of middle plate510, into inner deflation zone 555, through opening 565, throughdeflation port 540, into bulb 310, back out of bulb 310 into inflationport 535, through opening 570 in outer inflation zone 560, into outerinflation zone 560, and through outer hole 605 of middle plate 510 andinto atmosphere. It should be appreciated that as this occurs, aftballoon inflation port 660, aft balloon deflation port 665 and foreballoon inflation port 670 are all fluidically sealed against topsurface 590 of middle plate 510 so that air cannot enter or leave ports660, 665, 670, and hence, when manifold 500 is in State 4, deflation offore balloon 35 does not have any effect on aft balloon 20.

5. Fore Balloon and Aft Balloon Sealed Against Inflation/Deflation.

When middle plate 510 is disposed in State 5 discussed above (i.e., whenmiddle plate 510 is rotated such that inner hole 600 and outer hole 605are both open to atmosphere), aft balloon inflation port 660, aftballoon deflation port 665, fore balloon inflation port 670 and foreballoon deflation port 675 are all sealed against top surface 590 ofmiddle plate 510. In State 5, squeezing and releasing of bulb 310 has noeffect on either fore balloon 35 or aft balloon 20 (inasmuch as air isdrawn into inner hole 600 of middle plate 510, enters inner deflationzone 555, passes through opening 565, passes out deflation port 540 andinto bulb 310, and is then passed from bulb 310, into inflation port535, through opening 570 and into outer inflation zone 560, and then outthrough outer hole 605 to atmosphere).

Alternative Novel Manifold

It should be appreciated that other manifolds may be utilized ininflation mechanism 40 in place of the novel manifold 500 discussedabove.

By way of example but not limitation, and looking now at FIG. 79, thereis shown another novel manifold 500A for selectively inflating ordeflating a selected one of aft balloon 20 and fore balloon 35. Manifold500A serves the same function as manifold 500 discussed above (i.e.,manifold 500A selectively controls a plurality of airway paths in orderto permit a user to selectively inflate or deflate a selected one of aftballoon 20 and fore balloon 35 using a single user interface), however,manifold 500A employs a somewhat different construction than manifold500.

Looking now at FIG. 80, manifold 500A generally comprises a rotatablecontrol dial and a plurality of tubes (labelled 1-6 in FIG. 80), withthe control dial being configured to selectively close-off one or moreof the plurality of tubes and to selectively open one or more of theplurality of tubes as the rotatable control dial is rotated. Moreparticularly, and still looking at FIG. 80, there is shown a rotatablecontrol dial 800 comprising a body 805. Body 805 comprises a firstgroove 810 having a first cutout section 815 and a second cutout section820, a second groove 825 having a first cutout section 830 and a secondcutout section 835, a third groove 840 having a cutout section 845, afourth groove 850 having a cutout section 855, a fifth groove 860 havinga cutout section 865 and a sixth groove 870 having a cutout section 875.

The plurality of tubes discussed above are fixed in place relative torotatable control dial 800 and each of the plurality of tubes passesthrough one of first groove 810, second groove 825, third groove 840,fourth groove 850, fifth groove 860 and sixth groove 870. Moreparticularly, a first tube 880 in fluid connection with bulb 310 andatmosphere passes through first groove 810, a second tube 885 in fluidconnection with bulb 310 and atmosphere passes through second groove825, a third tube 890 in fluid connection with aft balloon 20 and bulb310 passes through third groove 840, a fourth tube 895 in fluidconnection with aft balloon 20 and bulb 310 passes through fourth groove850, a fifth tube 900 in fluid connection with fore balloon 35 and bulb310 passes through fifth groove 860, and a sixth tube 905 in fluidconnection with fore balloon 35 and bulb 310 passes through sixth groove870.

First groove 810, second groove 825, third groove 840, fourth groove850, fifth groove 860 and sixth groove 870 are sized such that firsttube 880, second tube 885, third tube 890, fourth tube 895, fifth tube900 and sixth tube 905 are “pinched off” such that air cannot flow throwthe tube whenever the tube is disposed in a section of its respectivegroove 810, 825, 840, 860, 870 which is not a cutout section. As aresult, air can only flow through a given tube 880, 885, 890, 895, 900,905 when the tube is disposed in a cutout section formed in the groovethat the tube is disposed in.

More particularly, first tube 880 only permits passage of air throughthe tube when it is disposed in either cutout section 815 or cutoutsection 820 of first groove 810, second tube 885 only permits passage ofair through the tube when it is disposed in either cutout section 830 orcutout section 835, third tube 890 only permits passage of air throughthe tube when it is disposed in cutout section 845, etc. Since tubes880, 885, 890, 895, 900 and 905 are fixed in location relative tocontrol dial 800, when control dial 800 is selectively rotated by auser, cutout sections 815, 820, 830, 835, 845, 855, 865 and 875 moverelative to tubes 880, 885, 890, 895, 900 and 905. By controlling wherethe cutout sections 815, 820, 830, 835, 845, 855, 865 and 875 are formedin body 805 of control dial 800, it is possible to control which of thetubes 880, 885, 890, 895, 900 and 905 will be “pinched off” and whichwill reside in a cutout section 815, 820, 830, 835, 845, 855, 865 and875 when control dial 800 is rotated to a given position. Thus it ispossible to control the flow of air to and from bulb 310, and tosimultaneously control the flow of air to and from a selected one of aftballoon 20 and fore balloon 35, by selectively moving control dial 800to a specific position. Further details regarding the flow of airthrough manifold 500A are provided in FIGS. 81 and 82.

Venting of Balloons Through Packaging Design

In one preferred form of the present invention, and looking now at FIG.83, novel apparatus 5 is sealed within a sterile package 1000 untilnovel apparatus 5 is to be used. Package 1000 is typically provided inthe form of a bottom tray 1005 which is sized to hold novel apparatus 5,and a cover 1010 for mating to, and sealing off, bottom tray 1005. Foreballoon 35 and aft balloon 20 are in their deflated condition when novelapparatus 5 is sealed within sterile package 1000.

While fore balloon 35 and aft balloon 20 are stored within package 1000in their deflated condition, it has been found that it is sometimespossible for a small amount of residual air to remain within foreballoon 35 and/or aft balloon 20 and/or the various fluid pathwaysleading to fore balloon 35 and/or aft balloon 20 (e.g., hollow pushtubes 30, push tube bridge 31, proximal inflation/deflation tube 45,etc.). As a result, when novel apparatus 5 (sealed within package 1000)is thereafter shipped to a recipient via a means of transportation wherepackage 1000 is exposed to a substantial change in air pressure (e.g.,when novel apparatus 5 is shipped to a recipient via an airplane), thechange in air pressure can cause the residual air remaining within foreballoon 35 and/or aft balloon 20 (and/or the various fluid pathwaysleading to fore balloon 35 and/or aft balloon 20) to expand. Suchexpansion while novel apparatus 5 is sealed within package 1000 cancause damage to fore balloon 35, aft balloon 20 and/or other componentsof novel apparatus 5.

One possible solution to the foregoing problem is to fully evacuate allof the air from fore balloon 35, aft balloon 20 and all of the pathways,leading to fore balloon 35 and aft balloon 20 before novel apparatus 5is sealed within package 1000. However, it has been found that it can bechallenging to evacuate all of the air from fore balloon 35, aft balloon20 and the pathways leading to fore balloon 35 and aft balloon 20. Inaddition, it has also been found that it can be challenging to ensurethat no air is thereafter able to leak back into any of the evacuatedcomponents of novel apparatus 5.

Another possible solution is to allow the air within the interior ofpackage 1000 to freely enter and exit the components of novel apparatus5, e.g., by leaving one or both of fittings 46, 56 open to airflow, etc.However, with such an “open valve” configuration, the recipient (e.g.,the surgeon) would need to be diligent in closing any open valves priorto using novel apparatus 5. It is possible that a recipient mayinadvertently leave a valve open that should be closed prior to usingnovel apparatus 5, thereby causing malfunction of novel apparatus 5.

Thus there is a need for a new and improved way to maintain a freeexchange of air between the interior of package 1000 and fore balloon 35and aft balloon 20, while automatically sealing off that free exchangeof air when the user removes novel apparatus 5 from package 1000.

To this end, and looking now at FIG. 84, a fore balloon venting checkvalve 1015 and an aft balloon venting check valve 1015A are provided inhand inflator 300, with fore balloon venting check valve 1015 beingdisposed in fore balloon inflation line 320 and with aft balloon ventingcheck valve 1015A being disposed in aft balloon inflation line 315. Forclarity of illustration, only fore balloon venting check valve 1015 isshown in FIGS. 85-88 and discussed in detail hereinbelow, however, itshould be appreciated that aft balloon venting check valve 1015A isidentical in construction and function to fore balloon venting checkvalve 1015 (although aft balloon venting check valve 1015A is disposedin aft balloon inflation line 315 rather than in fore balloon inflationline 320).

Looking now at FIGS. 85-88, fore balloon venting check valve 1015 andaft balloon venting check valve 1015A are disposed in the bottom surfaceof housing 305 of hand inflator 300, such that they are in fluidcommunication with fore balloon inflation line 320 and aft ballooninflation line 315, respectively, and hence in fluid communication withfore balloon 35 and aft balloon 20, respectively. More particularly,fore balloon venting check valve 1015 comprises a lumen 1020 having afirst end in fluid communication with fore balloon inflation line 320and a second end having an opening 1025 formed in the outer surface ofhousing 305. A ball (e.g., a rubber ball) 1030 is movably disposedwithin lumen 1020 and is biased against opening 1025 by a spring 1035.When ball 1030 is biased against opening 1025, air cannot pass throughopening 1025 and into (or out of) fore balloon inflation line 320, i.e.,fore balloon 35 is sealed off against the free passage of air into (orout of) fore balloon 35.

Bottom tray 505 comprises an upwardly-extending finger 1040 which issized and positioned such that finger 1040 is received within opening1025 of housing 305 when novel apparatus 5 (and, more specifically, handinflator 300) is disposed within bottom tray 1005 of package 1000.Finger 1040 is sized such that when it is received within opening 1025,a finger 1040 engages ball 1030 and drives ball 1030 against the powerof spring 1035, whereby to unseat ball 1030 from opening 1025. At thesame time, a gap remains between finger 1040 and the sides of opening1025, whereby to allow air to pass from the interior of package 1000through fore balloon venting check valve 1015, through fore ballooninflation line 320 and into fore balloon 35, and vice versa (FIG. 87).

Bottom tray 1005 comprises a similar finger 1040A for forcing checkvalve 1015A open when hand inflator 300 is seated in bottom tray 1005 ofpackage 1000.

If desired, an upwardly-extending stop (not shown) may also be providedon bottom tray 1005 of package 1000 for engaging the bottom surface ofhousing 305 of hand inflator 300 when hand inflator 300 is disposedwithin bottom tray 1005 of package 1000, whereby to ensure that an airgap is maintained between the bottom surface of hand inflator 300 andthe bottom surface of bottom tray 1005, and hence ensure that air isfree to flow through check valves 1015, 1015A when hand inflator 300 isseated in bottom tray 1005 of package 1000.

As a result of this construction, when novel apparatus 5 is disposed inbottom tray 1005, fingers 1040, 1040A open fore balloon venting checkvalve 1015 and aft balloon venting check valve 1015A, respectively, sothat air is permitted to freely enter into, and exit out of, foreballoon 35 and aft balloon 20 via fore balloon venting check valve 1015and aft balloon venting check valve 1015A, respectively. This eliminatesthe aforementioned problems associated with exposing package 1000 tosubstantial changes in air pressure (e.g., during shipping) and preventsdamage to apparatus 5 during shipping.

When apparatus 5 is to be used, cover 1010 is removed from package 1000and novel apparatus 5 is removed from bottom tray 1005. When thisoccurs, fingers 1040, 1040A are withdrawn from fore balloon ventingcheck valve 1015 and aft balloon venting check valve 1015A,respectively, thereby allowing these check valves to return to their“closed” positions.

Thus it will be seen that fore balloon venting check valve 1015 and aftballoon venting check valve 1015A act to protect novel apparatus 5 fromexposure to air pressure differentials during shipping/storage and doesso in a passive fashion that does not require the recipient to close anyvalves.

Preferred Method of Using the Novel Apparatus

Apparatus 5 may be used to manipulate, (e.g., stabilize, straighten,expand and/or flatten, etc.) the side wall of a body lumen and/or bodycavity so as to better present the side wall tissue (includingvisualization of areas which may be initially hidden from view oroutside the field of view) for examination and/or treatment during anendoscopic procedure using endoscope 10, and/or to stabilize the distaltips and/or working ends of instruments (e.g., graspers, cutters ordissectors, cauterizing tools, ultrasound probes, etc.), e.g., advancedinto the therapeutic zone.

More particularly, in use, sleeve 15 is first mounted to endoscope 10(FIG. 1). This may be accomplished by pulling base 25 proximally overthe distal end of endoscope 10 and then pulling proximally along thelength of endoscope 10 until the distal end of sleeve 15 issubstantially aligned with the distal tip of endoscope 10. At thispoint, aft balloon 20 is deflated, fore balloon 35 is deflated, and foreballoon 35 is docked over the distal end of endoscope 10, with endoscope10 nesting in the area beneath raised push tube bridge 31. Endoscope 10and apparatus 5 are ready to be inserted as a unit into the patient.

Looking next at FIG. 89, endoscope 10 and apparatus 5 are inserted as aunit into a body lumen and/or body cavity of the patient. By way ofexample but not limitation, endoscope 10 and apparatus 5 are inserted asa unit into the gastrointestinal (GI) tract of the patient. Endoscope 10and apparatus 5 are advanced along the body lumen and/or body cavity toa desired location within the patient (FIGS. 90 and 91).

When apparatus 5 is to be used (e.g., to manipulate the side wall of thegastrointestinal tract so as to provide increased visualization of thesame and/or increase access to the same, and/or for stabilizinginstruments relative to the same), aft balloon 20 is inflated so as tostabilize apparatus 5 (and hence endoscope 10) within the body lumenand/or body cavity. See FIG. 92. This may be done using theaforementioned associated inflation mechanism 40.

In this respect it will be appreciated that inasmuch as the articulatingportion of the endoscope resides distal to aft balloon 20, the endoscopewill be able to articulate distal to aft balloon 20 so as to facilitatevisualization of the anatomy even after aft balloon 20 is inflated.Significantly, such visualization is enhanced, inasmuch as aft balloon20 stabilizes endoscope 10 within the gastrointestinal tract anddistends the colon and increases the colon to a fixed diameter directlyadjacent to aft balloon 20.

Next, hollow push tubes 30 are advanced distally in the body lumenand/or body cavity (i.e., so as to move fore balloon 35 further ahead ofaft balloon 20) by pushing distally on push tube handle 37. Thus, hollowpush tubes 30, and hence fore balloon 35, move distally relative toendoscope 10 (which is stabilized in position within thegastrointestinal tract by the inflated aft balloon 20). Note that raisedpush tube bridge 31 provides an atraumatic tip for the distal ends ofhollow push tubes 30, thereby ensuring atraumatic advancement of foreballoon 35. Note that the deflated fore balloon 35 covers the distalends of hollow push tubes 30 and raised push tube bridge 31 during suchdistal advancement of fore balloon 35, thereby ensuring atraumaticadvancement of fore balloon 35. Note that atraumatic advancement of foreballoon 35 may be further enhanced by forming the distal ends of hollowpush tubes 30 and raised push tube bridge 31 out of a more resilientmaterial.

When hollow push tubes 30 have advanced fore balloon 35 to the desiredposition distal to endoscope 10, fore balloon 35 is inflated (FIG. 93)so as to secure fore balloon 35 to the anatomy. Again, this may be doneusing the aforementioned associated inflation mechanism 40. As foreballoon 35 is inflated, the inflated fore balloon 35, the inflated aftballoon 20, and hollow push tubes 30 will all complement one another soas to stabilize, straighten, expand and/or flatten the side wall of thebody lumen and/or body cavity so as to better present the side walltissue (including visualization of areas which may be initially hiddenfrom view or outside the field of view) for examination and/or treatmentduring an endoscopic procedure using endoscope 10. In this respect itwill be appreciated that the inflated fore balloon 35 and the inflatedaft balloon 20 will together expand and tension the side wall of thebody lumen and/or body cavity, and hollow push tubes 30 will tend tostraighten the anatomy between the two inflated balloons when the foreballoon is extended distally from the aft balloon. In this respect itwill also be appreciated that once aft balloon 20 and fore balloon 35have both been inflated, fore balloon 35 will create a substantiallyfull-diameter seal across the body lumen and/or body cavity (because theinflated fore balloon closes down the axial opening 63 extending throughthe fore balloon when the fore balloon is in its deflated state), andaft balloon 20 will cooperate with sleeve 15 and endoscope 10 to createanother substantially full-diameter barrier across the body lumen and/orbody cavity. Thus, the inflated fore balloon 35 and the inflated aftballoon 20 will together define a substantially closed region along thebody lumen and/or body cavity (i.e., an isolated therapeutic zone whichprevents the passage of fluid and/or other liquids by virtue of theair-tight seals established by the inflated fore balloon 35 and aftballoon 20). The side wall of the body lumen and/or body cavity will betensioned by inflation of fore balloon 35 and aft balloon 20, whereby tobetter present the side wall of the body lumen and/or body cavity forviewing through endoscope 10.

It should be appreciated that the expansion and tensioning of the sidewall of the body lumen and/or body cavity effected by the inflated foreballoon 35, the inflated aft balloon 20, and hollow push tubes 30, canbe further enhanced by advancing the fore balloon when it is inflatedand gripping the side wall of the body lumen and/or body cavity, wherebyto further tension the side wall of the body lumen and/or body cavity.

Significantly, inasmuch as the inflated fore balloon 35 and the inflatedaft balloon 20 together define a substantially closed region along thebody lumen and/or body cavity (i.e., an isolated therapeutic zone), thisregion can then be inflated (FIG. 24) with a fluid (e.g., air, CO₂,etc.) so as to further tension the side wall of the body lumen and/orbody cavity, whereby to better present the side wall of the body lumenand/or body cavity for viewing through endoscope 10 and stabilize theside wall so as to facilitate more precise therapeutic interventions.

If desired, fore balloon 35 can be retracted toward aft balloon 20(i.e., by pulling push tube handle 37 proximally), while remaininginflated (and hence maintaining a grip on the side wall of the bodylumen and/or body cavity), so as to move the visible mucosa and furtherimprove visualization and access (see FIG. 95), e.g., so as to positiona particular target area on the side wall of the body lumen and/or bodycavity at a convenient angle relative to the endoscope and endoscopictools.

Alternatively, if desired, once aft balloon 35 has been inflated, hollowpush tubes 30 may be advanced distally a portion—but only a portion—oftheir full distal stroke, then fore balloon 35 may be inflated so as togrip the side wall of the body lumen and/or body cavity, and then hollowpush tubes 30 may be further advanced distally. This action will causeflexible hollow push tubes 30 to bow outwardly (see FIGS. 96-99),contacting the side wall of the body lumen and/or body cavity andpushing the side wall of the body lumen and/or body cavity outwardly,e.g., in a “tenting” fashion, whereby to further enhance visualizationof the side wall of the body lumen and/or body cavity by endoscope 10.

If desired, instruments 190 (FIG. 100) may be advanced through workingchannels of endoscope 10 so as to biopsy and/or treat pathologicconditions (e.g., excise pathological anatomy). It will be appreciatedthat such instruments will extend through the distal end of theendoscope, which is effectively stabilized relative to the anatomy viaaft balloon 20, so that the working ends of instruments 190 will also behighly stabilized relative to the anatomy. This is a significantadvantage over the prior art practice of advancing instruments out ofthe non-stabilized end of an endo scope. Preferably instruments 190include articulating instruments having a full range of motion, wherebyto better access target anatomy.

Furthermore, if bleeding were to obscure a tissue site, or if bleedingwere to occur and the surgeon is unable to identify the source of thebleeding, the isolated therapeutic zone permits rapid flushing of theanatomic segment in which the therapeutic zone lies (e.g., with a liquidsuch as saline) with rapid subsequent removal of the flushing liquid(see FIGS. 101-103).

Also, if desired, fore balloon 35 can be directed with high precision toa bleeding site, whereupon fore balloon 35 may be used (e.g., inflated)to apply local pressure to the bleeding site in order to enhancebleeding control (see FIG. 104). This can be done under thevisualization provided by endoscope 10.

If it is desired to reposition endoscope 10 within the anatomy withminimal interference from apparatus 5, fore balloon 35 is returned toits torus configuration (i.e., partially deflated), the fore balloon isretracted proximally and “re-docked” on the distal end of endoscope 10(with endoscope 10 nesting in the area beneath raised push tube bridge31), aft balloon 20 is deflated, and then endoscope 10 (with apparatus 5carried thereon) is repositioned within the anatomy. Note that wherefore balloon 35 is to be re-docked on the distal end of endoscope 10,fore balloon 35 is preferably only partially deflated until fore balloon35 is re-docked on the distal end of the endoscope, since partialinflation of fore balloon 35 can leave fore balloon 35 with enough“body” to facilitate the re-docking process. Thereafter, fore balloon 35may be fully deflated if desired, e.g., so as to positively grip thedistal end of endoscope 10.

Alternatively, if desired, fore balloon 35 may be used as a drag braketo control retrograde motion of the endoscope. More particularly, inthis form of the invention, endoscope 10 and apparatus 5 are firstadvanced as a unit into the body lumen and/or body cavity until the tipof the endo scope is at the proper location. Next, aft balloon 20 isinflated, hollow push tubes 30 are advanced distally, and then foreballoon 35 is inflated (FIG. 105). Visualization and, optionally,therapeutic treatment may then be effected at that location. When theapparatus is to be moved retrograde, aft balloon 20 is deflated, foreballoon 35 is partially deflated, and then the endoscope is withdrawnproximally, dragging the semi-inflated fore balloon 35 along the bodylumen and/or body cavity (FIG. 106), with fore balloon 35 acting assomething of a brake as the endoscope is pulled proximally, therebyenabling more controlled retrograde movement of the endoscope and hencebetter visualization of the anatomy. If at some point it is desired, aftballoon 20 and fore balloon 35 can be re-inflated, as shown in FIG. 107,with or without introduction of a fluid into the “isolated therapeuticzone” established between the two balloons, so as to stabilize,straighten, expand and/or flatten the anatomy.

It is also possible to use aft balloon 20 as a brake when withdrawingthe endoscope (and hence apparatus 5) from the anatomy, either alone orin combination with the aforementioned braking action from fore balloon35.

At the conclusion of the procedure, endoscope 10 and apparatus 5 arewithdrawn from the anatomy. Preferably this is done by deflating (orpartially deflating) fore balloon 35, retracting hollow push tubes 30 sothat fore balloon 35 is “re-docked” onto the distal end of endoscope 10(with endoscope 10 nesting in the area beneath raised push tube bridge31), fully deflating fore balloon 35 so that it grips the distal end ofthe endoscope, deflating aft balloon 20 (if it is not yet deflated), andthen withdrawing endoscope 10 and apparatus 5 as a unit from theanatomy.

It should be appreciated that apparatus 5 may also be usedadvantageously in various ways other than those disclosed above. By wayof example but not limitation, when endoscope 10 (and apparatus 5) is tobe advanced within the colon, it may be desirable to first project foreballoon 35 distally under visual guidance of the endoscope so that foreballoon 35 leads the distal end of the endoscope. As a result, when theendoscope is advanced distally, with fore balloon 35 being deflated (orpartially deflated), the fore balloon and flexible hollow push tubes 30(and raised push tube bridge 31) may act as an atraumatic lead (guidingstructure) for the endoscope as the endoscope advances through thecolon. Significantly, inasmuch as the distal ends of hollow push tubes30 are preferably highly flexible, as the advancing fore balloon 35encounters the colon wall (e.g., at a turn of the colon), the flexiblehollow push tubes can deflect so that the fore balloon tracks the pathof the colon, thereby aiding atraumatic advancement of the endo scopealong the colon. It should also be appreciated that apparatus 5 may alsobe used advantageously in other ways to facilitate further examinationsof the luminal surface otherwise difficult to be performed currently.Such an example is endoscopic ultrasound examination of the lumen whichwould be facilitated by the fluid-filled inflated fore balloon andultrasound probe examination.

Improved Aft Balloon Thermal Bonding Using Insert Material

Aft balloon 20 is bonded to sleeve 15 along at least the distal edge ofaft balloon 20 and the proximal edge of aft balloon 20 (i.e., the distaland proximal edges where aft balloon 20 meets sleeve 15), such that anairtight seal is created between aft balloon 20 and sleeve 15. Pushrodlumens 52 and aft balloon inflation lumen 47 are disposed in contactwith, and parallel to, sleeve 15, with pushrod lumens 52 passingentirely through aft balloon 20 (i.e., through both the proximal anddistal edges of aft balloon 20 where aft balloon 20 meets sleeve 15) andwith aft balloon inflation lumen 47 passing through the proximal edge ofaft balloon 20 and extending into the interior of aft balloon 20. As aresult, aft balloon 20 must be sealingly bonded to sleeve 15 about aseries of components (i.e., pushrod lumens 52 and aft balloon inflationlumen 47) which collectively present a non-circular cross-sectionalprofile at the bonding sites.

In practice, it has been found that it is challenging to effect airtightthermal bonding of aft balloon 20 to sleeve 15, inasmuch as the presenceof pushrod lumens 52 and aft balloon inflation lumen 47 create openwedges (or corners) which the material of aft balloon 20 must fill inorder to ensure airtight bonding of aft balloon 20 to sleeve 15.

More particularly, and looking now at FIG. 108, gaps 1100 exist in thespace between pushrod lumens 52 and sleeve 15, gap 1105 exists in thespace between aft balloon inflation lumen 47 and sleeve 15, and gaps1110 exist in the space between a pushrod lumen 52 and aft ballooninflation lumen 47. The presence of gaps 1100, 1105 and 1110 at theproximal edge of aft balloon 20, and the presence of gaps 1100 at thedistal edge of aft balloon 20, compromise the airtight sealing of aftballoon 20 to sleeve 15, since it is difficult to make the material ofaft balloon 20 adhere to the irregular perimeter defined by pushrodlumens 52 and aft balloon inflation lumen 47. Stated another way, it canbe challenging to make the material of aft balloon 20 enter into gaps1100, 1105 and 1110.

Thus it would be desirable to provide a new and improved means to fillgaps 1100, 1105 and 1110 so that aft balloon 20 can be thermally bondedto sleeve 15 in an airtight sealing engagement.

To that end, and looking now at FIGS. 109, 110, 111, 112, 113 and 114,there are provided novel extruded inserts 1115 which have across-sectional profile matching the aforementioned gaps 1100. Extrudedinserts 1115 are sized to fill gaps 1100 at the location where theproximal edge of aft balloon 20 and the distal edge of aft balloon 20are bonded to sleeve 15 around pushrod lumens 52. Extruded inserts 1110are preferably flexible and may be of any desired length (e.g., extrudedinserts 1115 may extend along substantially the entire length of sleeve15, or extruded inserts 1115 may extend only along a portion of sleeve15 where aft balloon 20 is bonded to sleeve 15, or a plurality ofextruded inserts 1115 may extend along a plurality of interruptedsections of sleeve 15, etc.). In one preferred form of the invention,extruded inserts 1115 extend from a location just distal to aft balloon20 to a location just proximal to aft balloon 20.

There is also provided a novel extruded insert 1120 having across-sectional profile matching the aforementioned gap 1105. Extrudedinsert 1120 is sized to fill gap 1105 at the location where the proximaledge of aft balloon 20 and the distal edge of aft balloon 20 are bondedto sleeve 15 around aft balloon inflation lumen 47. Extruded insert 1120is preferably flexible and may be of any desired length (e.g., extrudedinserts 1120 may extend along substantially the entire length of sleeve15, or extruded inserts 1120 may extend only along a portion of sleeve15 where aft balloon 20 is bonded to sleeve 15, or a plurality ofextruded inserts 1120 may extend along a plurality of interruptedsections of sleeve 15, etc.). In one preferred form of the invention,extruded insert 1120 extends from a location at the distal end of aftballoon inflation lumen 47 to a location just proximal to aft balloon20.

There are also provided novel extruded inserts 1125 having across-sectional profile matching the aforementioned gaps 1110. Extrudedinserts 1125 are sized to fill gaps 1110 at the location where theproximal edge of aft balloon and the distal edge of aft balloon 20 arebonded to sleeve 15 around aft balloon inflation lumen 47 and a pushrodlumen 52. Extruded inserts 1125 are preferably flexible and may be ofany desired length (e.g., extruded inserts 1125 may extend alongsubstantially the entire length of sleeve 15, or extruded inserts 1125may extend only along a portion of sleeve 15 where aft balloon 20 isbonded to sleeve 15, or a plurality of extruded inserts 1125 may extendalong a plurality of interrupted sections of sleeve 15, etc.). In onepreferred form of the invention, extruded insert 1125 extends from alocation at the distal end of aft balloon inflation lumen 47 to alocation just proximal to aft balloon 20.

Inserts 1115, 1120 and 1125 are preferably formed out of a materialwhich will thermally bond with the material(s) of (i) sleeve 15, (ii)pushrod lumens 52, (iii) aft balloon inflation lumen 47, and (iv) aftballoon 20, whereby to facilitate the airtight bonding of aft balloon 20to sleeve 15, pushrod lumen 52 and aft balloon inflation lumen 47.

It should be appreciated that where additional components/lumens (e.g.,working channels) are disposed coaxially about sleeve 15, additionalextruded inserts 1115, 1120, 1125, etc. may be provided, and/or otherextruded inserts of different sizes and/or cross-sectional profiles maybe provided, without departing from the scope of the present invention.

Improved Fore Balloon Construction

With the “double eversion” fore balloon construction discussed above,fore balloon 35 is formed as a hollow balloon body 67 having twoextensions (i.e., proximal extension 73 and distal extension 76) whichare both everted inwardly (i.e., the proximal extension is evertedfirst, the distal extension is everted second) into the interior of body67 and thermally bonded together to form fore balloon 35. With thisapproach, fore balloon 35 comprises a torus, whereby to facilitatedocking of fore balloon 35 over the distal end of sleeve 15 (i.e., thedistal end of endoscope 10) when fore balloon 35 is in its deflatedcondition. At the same time, fore balloon 35 can provide a full-diameterbarrier across an anatomical passageway when fore balloon 35 is in itsinflated condition.

However, it has been found that it can be challenging to effect goodthermal bonding between inwardly-everted proximal extension 73 andinwardly-everted distal extension 76, inasmuch as both proximalextension 73 and distal extension 76 are located within the interiorbody 67 of fore balloon 35 during bonding, and therefore can bedifficult to access during component bonding.

One solution to this problem, and looking now at FIGS. 115-119, is theprovision of an alternative fore balloon 35A. Fore balloon 35A ismanufactured as a single construct comprising a body 67A having aproximal opening 69A and a distal opening 71A, a proximal extension 73Ahaving a “key-shaped” cross-section comprising lobes 74A, and a distalextension 76A having a circular cross-section. Note that lobes 74A ofproximal extension 73A have a configuration that matches theconfiguration of hollow push tubes 30 (i.e., where apparatus 5 comprisestwo hollow push tubes 30 diametrically opposed to one another, proximalextension 73A comprises two lobes 74A diametrically opposed to oneanother—for the purposes of the present invention, proximal extension73A and lobe(s) 74A may be collectively referred to as having a“key-shaped” cross-section). Proximal extension 73A is relatively shortand is preferably flared outwardly at its proximal end, whereby tofacilitate docking of fore balloon 35A over sleeve 15 and/or endoscope10 as will hereinafter be discussed in greater detail. Furthermore,proximal extension 73A preferably comprises a proximally-extendingtongue 77 for facilitating docking of fore balloon 35A over the proximalend of sleeve 15 (and/or the proximal end of endoscope 10).

Thus it will be appreciated that fore balloon 35A is formed in a mannergenerally similar to the aforementioned fore balloon 35, except thatproximal extension 73A of fore balloon 35A differs from theaforementioned proximal extension 73 of fore balloon 73 (i.e., by beingformed with a shorter length, a flared proximal end and a tongue 77).

Fore balloon 35A is also assembled in a somewhat different manner thanthe aforementioned fore balloon 35, as will hereinafter be discussed ingreater detail. More particularly, and looking now at FIGS. 120-122,hollow push tubes 30 are seated in lobes 74A of proximal extension 73A,with proximal extension 73A extending proximally away from fore balloon35A and with distal extension 76 extending distally away from foreballoon 35A. Hollow push tubes 30 are advanced distally into theinterior of body 67A of fore balloon 35A such that the interiors ofhollow push tubes 30 are in fluid communication with the interior ofbody 67A and with raised push tube bridge 31 disposed within theinterior of body 67A. If desired, an assembly mandrel M may be usedduring assembly in order to provide support for the components duringinsertion of hollow push tubes 30 into fore balloon 35A of fore balloon35A (see FIG. 120).

Next, processing mandrel M is removed (if one is used), and distalextension 76A is everted into the interior of body 67A of fore balloon35A and passed proximally through body 67A, and through the interior ofproximal extension 73A, until distal extension 76A extends to theproximal opening of proximal extension 73A. As a result of thisconstruction, proximal extension 76A extends through body 67A, and bothproximal extension 73A and distal extension 76A extend proximally awayfrom body 67A of fore balloon 35A, and push tubes 30 are disposedbetween proximal extension 73A and distal extension 76A proximal to body67A of fore balloon 35A. Thus, in this form of the invention, proximalextension 73A is not everted into the interior of fore balloon 35A,rather, proximal extension 73A remains extending proximally away fromfore balloon 35.

Proximal extension 73A and distal extension 76A are then bonded togetherat their proximal ends, with push tubes 30 being sealed therebetween,such that airtight thermal bonding is effected.

As a result of the foregoing, fore balloon 35A has a toroidalconfiguration, comprising a boy 67 having a center opening formed by (i)proximal extension 73A/everted distal extension 76A on the proximal sideof body 67A, and (ii) everted distal extension 76A within the interiorof body 67A.

Significantly, this form of the invention results in fore balloon 35Ahaving a toroidal shape which does not require thermal bonding to becarried out within the interior of body 67A of fore balloon 35A, therebysimplifying assembly. Furthermore, by forming proximal extension 73A asa relatively short structure having an outwardly flared proximal end,and by providing tongue 77 on the proximal edge of proximal extension73A, proximal extension 73A can facilitate docking of fore balloon 35Aover sleeve 15 and/or endoscope 10.

If desired, and looking now at FIG. 123, novel extruded inserts 1130 maybe provided alongside hollow push tubes 30 so as to facilitate bondinghollow push tubes 30 to proximal extension 73A and to the everted distalextension 76A.

Furthermore, if desired, additional material and/or extrusions may beprovided along either (or both of) proximal extension 73A and distalextension 76A, and/or around the proximal opening of proximal extension73A, so as to provide increased rigidity to those portions of foreballoon 35A.

Forming the Aft Balloon with an Everted Construction

If desired, aft balloon 20 may be formed with an everted construction.More particularly, and looking now at FIGS. 124 and 125, there is shownan aft balloon 20A which generally comprises a distal extension 1135 anda proximal extension 1140. During construction, distal extension 1135 iseverted back through the center of aft balloon 20A so as to form agenerally toroidal balloon structure which is secured to sleeve 15. Inthis form of the invention, a tube 1145 has its distal end 1150 disposedexterior to the everted distal extension 1135, and interior to theoutside wall of aft balloon 20A, and its proximal end 1155 connected tothe aforementioned proximal inflation/deflation tube 45, so that air (oranother fluid) can be introduced into aft balloon 20A and removed fromaft balloon 20A.

Additional Constructions

If desired, apparatus 5 may be constructed so that hollow push tubes 30may be advanced or retracted, to a limited extent, independently of oneanother, as well as in conjunction with one another—such limitedindependent advancement or retraction of hollow push tubes 30 can aid insteering the partially- or fully-deflated fore balloon 35 through thebody lumen and/or body cavity, whereby to facilitate advancement orretraction of endoscope 10 through the body lumen and/or body cavity,and/or such independent advancement or retraction of hollow push tubes30 can facilitate applying a “turning force” to the anatomy with aninflated fore balloon 35, whereby to better present the anatomy forvisualization and/or treatment.

By way of example but not limitation, in this form of the invention, andlooking now at FIG. 126, hollow push tubes 30 are each independentlyslidably mounted to push tube handle 37 so that hollow push tubes 30 canmove, to some extent, independently of push tube handle 37 and eachother. Stops 191 limit distal movement of hollow push tubes 30 relativeto push tube handle 37 so that a hollow push tube cannot be movedcompletely out of push tube handle 37. As a result of this construction,when fore balloon 35 is to be moved distally, hollow push tubes 30 aremoved distally, either together or, to the extent allowed by raised pushtube bridge 31, independently of one another. And when fore balloon isto be moved proximally, hollow push tubes 30 are moved proximally,either together or independently of one another, to the extent allowedby raised push tube bridge 31. At any point in a procedure, hollow pushtubes 30 can be moved, to the extent allowed by raised push tube bridge31, independently of one another so as to “turn” the fore balloon, e.g.,such as when fore balloon 35 is inflated and engaging the anatomy,whereby to apply a “turning force” to the anatomy, or where fore balloon35 is partially inflated and is being used as an atraumatic tip for theadvancing assembly, whereby to help “steer” the assembly through theanatomy. Note that raised push tube bridge 31 at the distal ends ofhollow push tubes 30 provides a limiting mechanism to limit the extentto which hollow push tubes 30 may be moved, longitudinally,independently of one another, in order to prevent excessive turning offore balloon 35, and/or hollow push tube cross-over, and/or hollow pushtube entanglement, and/or hollow push tube misalignment, etc. Note alsothat hollow push tubes 30 may be held in a particular disposition bymounting hollow push tubes 30 in the aforementioned clamp 53 (FIGS. 37and 60).

It should also be appreciated that it is possible to modify theconstruction of sleeve 15 so as to support instruments (or hollowinstrument guide tubes) external to endoscope 10. More particularly,looking again at FIGS. 5 and 6, it will be seen that in the constructionshown in FIGS. 5 and 6, sleeve 15 comprises a lumen 47 for receivinginflation/deflation tube 45 for inflating/deflating aft balloon 20, anda pair of lumens 52 for receiving support tubes 50 which receive pushtubes 30 for manipulating and inflating/deflating fore balloon 35.However, if desired, sleeve 15 may include additional lumens forsupporting instruments (or hollow instrument guide tubes) external toendoscope 10.

More particularly, and looking now at FIG. 127, there is shown an endview of another form of sleeve 15 which includes a plurality of lumens195 for slidably receiving instruments 190 therein. Note that, wheninflated, aft balloon 20 provides a secure platform for maintainingendoscope 10 and sleeve 15 within a body lumen or body cavity, withendoscope 10 and sleeve 15 centered within the body lumen or bodycavity. As a result, the distal ends of lumens 195 of sleeve 15 willalso be securely maintained within the body lumen or body cavity so asto provide a secure support for instruments advanced through lumens 195of sleeve 15.

The proximal ends of lumens 195 may extend to, and through, base 25, inwhich case instruments may be inserted into lumens 195 at base 25, orthe proximal ends of lumens 195 may terminate proximal to base 25 (butstill outside the body of the patient), in which case instruments may beinserted into lumens 195 intermediate sleeve 15. By way of example butnot limitation, where endoscope 10 is 180 cm in length and instruments190 are 60 cm in length, it can be advantageous to insert instruments190 into lumens 195 at a point closer to balloons 20, 35 (rather than atbase 25). Note that in FIG. 127, the lumen 47 for receivinginflation/deflation tube 45 and inflation/deflation tube 45 forinflating/deflating aft balloon 20 are not visible, since the view isdistal-facing and is taken at a location distal to where lumen 47 andinflation/deflation tube 45 terminate on sleeve 15.

FIGS. 128-131 show various instruments 190 extending out of lumens 195.Note that instruments 190 preferably comprise articulating instruments,e.g., graspers 190A in FIGS. 128-131, a cauterizing device 190B in FIGS.128-129, scissors 190C in FIGS. 130 and 131, and a suction device 190Din FIGS. 128-131.

It should be appreciated that where sleeve 15 comprises its centralpassageway for receiving endoscope 10, lumen 47 for receivinginflation/deflation tube 45, lumens 52 for receiving support tubes 50which receive hollow push tubes 30, and/or lumens 195 for slidablyreceiving instruments 190 therein, sleeve 15 is preferably formed by anextrusion process.

In one preferred form of the invention, lumen 47 for receivinginflation/deflation tube 45, lumens 52 for receiving support tubes 50which receive hollow push tubes 30, and/or lumens 195 for slidablyreceiving instruments 190 may have a fixed configuration (i.e., a fixeddiameter), so that sleeve 15 has a fixed outer profile.

In another preferred form of the invention, lumen 47 for receivinginflation/deflation tube 45, lumens 52 for receiving support tubes 50which receive hollow push tubes 30, and/or lumens 195 for slidablyreceiving instruments 190 may have an expandable configuration (i.e.,they may have a minimal profile when empty and expand diametrically asneeded when filled), so that the overall profile of sleeve 15 isminimized.

It should also be appreciated that where sleeve 15 comprises a pluralityof lumens 195 for slidably receiving instruments 190 therein, it can bedesirable to provide greater structural integrity to the distal ends oflumens 195 so as to provide improved support for the instruments 190received within lumens 195. To this end, a support ring may be providedat the distal end of sleeve 15, wherein the support ring providesopenings for the passage of hollow push tubes 30 and openings for thepassage of instruments 190. Note that the openings in such a supportring for the passage of instruments 190 preferably make a close fit withthe instruments so as to provide excellent instrument support at thedistal end of sleeve 15.

Alternatively and/or additionally, lumens 195 may accommodate hollowinstrument guide tubes which themselves accommodate instruments therein.Such hollow instrument guide tubes can provide greater structuralintegrity to the distal ends of lumens 195 so as to provide improvedsupport for the instruments 190 received within lumens 195.

And such hollow instrument guide tubes may be of fixed geometry or ofbendable or articulating geometry. See, for example, FIG. 132, whichshows hollow instrument guide tubes 200 extending out of lumens 195 andreceiving instruments 190 therein. Note that hollow instrument guidetubes 200 may be independently movable relative to one another (andindependently movable relative to sleeve 15). Note also that instruments190 preferably make a close fit with hollow instrument guide tubes 200so as to provide excellent instrument support at the distal end ofsleeve 15.

In another form of the present invention, the toroidal construction offore balloon 35 may be replaced by a “conventional” balloonconstruction, i.e., by a balloon having a substantially uniform,full-diameter cross-section. In this form of the invention, the deflatedfore balloon is not “docked” over the endoscope duringinsertion—instead, the deflated fore balloon resides alongside theendoscope during insertion; and in this form of the invention, the foreballoon is not “re-docked” back over the endoscope duringwithdrawal—instead, the balloon resides distal to the endoscope (oralongside the endoscope) during withdrawal. It will be appreciated that,in this form of the invention, the raised push tube bridge 31 can helpretain the deflated fore balloon alongside the endoscope.

Applications

Thus it will be seen that the present invention comprises the provisionand use of novel apparatus for manipulating the side wall of a bodylumen and/or body cavity so as to better present the side wall tissue(including visualization of areas which may be initially hidden fromview or outside the field of view) for examination and/or treatmentduring an endoscopic procedure, e.g., to straighten bends, “iron out”inner luminal surface folds and create a substantially static or stableside wall of the body lumen and/or body cavity which enables moreprecise visual examination (including visualization of areas which maybe initially hidden from view or outside the field of view) and/ortherapeutic intervention. By way of example but not limitation, thenovel apparatus can be used to stabilize, straighten, expand and/orflatten bends and/or curves and/or folds in the side wall of theintestine so as to better present the side wall tissue (includingvisualization of areas which may be initially hidden from view oroutside the field of view) for examination and/or treatment during anendoscopic procedure.

The present invention also comprises the provision and use of novelapparatus capable of steadying and/or stabilizing the distal tips and/orworking ends of instruments (e.g., endoscopes, articulating and/ornon-articulating devices such as graspers, cutters or dissectors,cauterizing tools, ultrasound probes, etc.) inserted into a body lumenand/or body cavity during an endoscopic procedure with respect to theside wall of the body lumen and/or body cavity, whereby to facilitatethe precision use of those instruments.

By way of example but not limitation, the present apparatus can providea stable platform (i.e., a stable endoscope, stable therapeutic toolsand a stable colon wall, all stable with respect to one another) for theperformance of numerous minimally-invasive procedures within a bodylumen and/or body cavity, including the stabilization of an endoscopeand/or other surgical instruments (e.g., graspers, cutters ordissectors, cauterizing tools, ultrasound probes, etc.) within the bodylumen and/or body cavity, e.g., during a lesion biopsy and/or lesionremoval procedure, an organ resection procedure, endoscopic submucosaldissection (ESD), endoscopic mucosal resection (EMR), etc., while at thesame time stabilizing the colon (including decreasing deformation of thecolon wall) so as to enable more precise visualization, interventionand/or surgery.

Significantly, the present invention provides novel apparatus capable ofsteadying and/or stabilizing the distal tips and/or working ends ofendoscopes (and hence also steadying and/or stabilizing the distal tipsand/or working ends of other instruments inserted through the workingchannels of those endoscopes, such as graspers, cutters or dissectors,cauterizing tools, ultrasound probes, etc.) with respect to the sidewall of the body lumen and/or body cavity, and stabilizing the side wallof the body lumen and/or body cavity relative to these instruments.

And the present invention provides novel apparatus capable of steadyingand/or stabilizing the distal tips and/or working ends of instruments(such as graspers, cutters or dissectors, cauterizing tools, ultrasoundprobes, etc.) advanced to the surgical site by means other than throughthe working channels of endoscopes.

The novel apparatus of the present invention can be used insubstantially any endoscopic procedure to facilitate the alignment andpresentation of tissue during an endoscopic procedure and/or tostabilize the working end of an endoscope (and/or other instrumentsadvanced through the endoscope) relative to tissue or to assist in theadvancement of the endoscope during such a procedure.

The present invention is believed to have widest applications withrespect to the gastrointestinal (GI) tract (e.g., large and smallintestines, esophagus, stomach, etc.), which is generally characterizedby frequent turns and which has a side wall characterized by numerousfolds and disease processes located on and between these folds. However,the methods and apparatus of the present invention may also be usedinside other body lumens (e.g., blood vessels, lymphatic vessels, theurinary tract, fallopian tubes, bronchi, bile ducts, etc.) and/or insideother body cavities (e.g., the head, chest, abdomen, nasal sinuses,bladder, cavities within organs, etc.).

MODIFICATIONS

While the present invention has been described in terms of certainexemplary preferred embodiments, it will be readily understood andappreciated by those skilled in the art that it is not so limited, andthat many additions, deletions and modifications may be made to thepreferred embodiments discussed above while remaining within the scopeof the present invention.

What is claimed is:
 1. Apparatus comprising: a sleeve adapted to be slidover an exterior of an endoscope; an aft balloon secured to the sleeve;an inflation/deflation tube carried by the sleeve and in fluidcommunication with an interior of the aft balloon; a pair of hollow pushtubes slidably mounted to the sleeve, wherein each of the hollow pushtubes comprises a distal end and a proximal end, the distal ends of thehollow push tubes being connected to one another with a raised push tubebridge, the raised push tube bridge being configured to nest anendoscope therein; and a fore balloon secured to the distal ends of thehollow push tubes, an interior of the fore balloon being in fluidcommunication with interiors of the pair of hollow push tubes, whereinthe fore balloon is capable of assuming a deflated condition and aninflated condition, and further wherein (i) when the fore balloon is inits deflated condition, an axial opening extends therethrough, the axialopening being sized to receive the endoscope therein, and (ii) when thefore balloon is in its inflated condition, the axial opening is closeddown.
 2. Apparatus according to claim 1 wherein the endoscope comprisesa proximal end and a distal end, wherein the proximal end of theendoscope comprises a handle, and further wherein the sleeve is sized soas to substantially cover the endoscope from a point adjacent to thedistal end of the endoscope to a point adjacent to the handle of theendoscope.
 3. Apparatus according to claim 1 wherein the sleeve isconfigured to make a close fit with the exterior of the endoscope suchthat the sleeve slides over the endoscope during mounting thereon butremains in place during use of the endoscope.
 4. Apparatus according toclaim 1 wherein the sleeve comprises a proximal end and a distal end,the apparatus further comprising a base secured to the sleeve at theproximal end of the sleeve.
 5. Apparatus according to claim 1 whereinthe inflation/deflation tube is formed integral with the sleeve. 6.Apparatus according to claim 1 wherein the sleeve comprises a pair ofpassageways for receiving the pair of hollow push tubes.
 7. Apparatusaccording to claim 6 wherein the pair of passageways are formed integralwith the sleeve.
 8. Apparatus according to claim 6 wherein each of thepair of passageways receives a support tube which receives a hollow pushtube.
 9. Apparatus according to claim 1 wherein the sleeve comprises alumen for receiving an instrument.
 10. Apparatus according to claim 9wherein the lumen is formed integral with the sleeve.
 11. Apparatusaccording to claim 10 wherein the lumen receives an instrument guidetube which receives an instrument.
 12. Apparatus according to claim 1wherein the endoscope is steerable, wherein the steerable endoscopecomprises an articulating portion, and further wherein the aft balloonis secured to the sleeve proximal to the articulating portion of thesteerable endoscope.
 13. Apparatus according to claim 1 wherein the aftballoon comprises a body having a proximal opening and a distal opening,a distal extension extending distally from the body, a proximalextension extending proximally from the body, and further wherein theaft balloon is formed by everting the distal extension into an interiorof the body and into an interior of the proximal extension. 14.Apparatus according to claim 1 wherein the raised push tube bridgecomprises an atraumatic tip.
 15. Apparatus according to claim 4 furthercomprising a push tube handle secured to the proximal ends of the hollowpush tubes, and further wherein the base is configured to support andguide the push tube handle as the push tube handle is used to move thepair of hollow push tubes relative to the sleeve.
 16. Apparatusaccording to claim 1 wherein the fore balloon comprises a body having aproximal opening and a distal opening, a proximal extension having akey-shaped cross-section comprising a pair of lobes, and a distalextension having a circular cross-section, and further wherein the foreballoon is formed by everting the distal extension into an interior ofthe body and into an interior of the proximal extension.
 17. Apparatusaccording to claim 16 wherein the pair of hollow push tubes are disposedin the lobes before the distal extension is everted into the interior ofthe body.
 18. Apparatus according to claim 16 wherein at least oneextruded insert is disposed adjacent to the lobes.
 19. Apparatusaccording to claim 1 wherein at least one of the sleeve, the aftballoon, the pair of hollow push tubes and the fore balloon comprises avisualizable marker.
 20. Apparatus according to claim 1 furthercomprising an inflation mechanism for selectively inflating/deflating aselected one of the fore balloon and the aft balloon.
 21. A method forperforming a procedure in a body lumen and/or body cavity, said methodcomprising: providing an apparatus comprising: a sleeve adapted to beslid over an exterior of an endoscope; an aft balloon secured to thesleeve; an inflation/deflation tube carried by the sleeve and in fluidcommunication with an interior of the aft balloon; a pair of hollow pushtubes slidably mounted to the sleeve, wherein each of the hollow pushtubes comprises a distal end and a proximal end, the distal ends of thehollow push tubes being connected to one another with a raised push tubebridge, the raised push tube bridge being configured to nest anendoscope therein; and a fore balloon secured to the distal ends of thehollow push tubes, an interior of the fore balloon being in fluidcommunication with interiors of the pair of hollow push tubes, whereinthe fore balloon is capable of assuming a deflated condition and aninflated condition, and further wherein (i) when the fore balloon is inits deflated condition, an axial opening extends therethrough, the axialopening being sized to receive the endoscope therein, and (ii) when thefore balloon is in its inflated condition, the axial opening is closeddown; positioning the apparatus in the body lumen and/or body cavity;inflating the aft balloon; advancing the pair of hollow push tubesdistally; inflating the fore balloon; and performing the procedure. 22.A method according to claim 21 wherein the endoscope comprises aproximal end and a distal end, wherein the proximal end of the endoscopecomprises a handle, and further wherein the sleeve is sized so as tosubstantially cover the endoscope from a point adjacent to the distalend of the endoscope to a point adjacent to the handle of the endoscope.23. A method according to claim 21 wherein the sleeve is configured tomake a close fit with the exterior of the endoscope such that the sleeveslides over the endoscope during mounting thereon but remains in placeduring use of the endoscope.
 24. A method according to claim 21 whereinthe sleeve comprises a proximal end and a distal end, the apparatusfurther comprising a base secured to the sleeve at the proximal end ofthe sleeve.
 25. A method according to claim 21 wherein theinflation/deflation tube is formed integral with the sleeve.
 26. Amethod according to claim 21 wherein the sleeve comprises a pair ofpassageways for receiving the pair of hollow push tubes.
 27. A methodaccording to claim 26 wherein the pair of passageways are formedintegral with the sleeve.
 28. A method according to claim 26 whereineach of the pair of passageways receives a support tube which receives ahollow push tube.
 29. A method according to claim 21 wherein the sleevecomprises a lumen for receiving an instrument.
 30. A method according toclaim 29 wherein the lumen is formed integral with the sleeve.
 31. Amethod according to claim 30 wherein the lumen receives an instrumentguide tube which receives an instrument.
 32. A method according to claim21 wherein the endoscope is steerable, wherein the steerable endoscopecomprises an articulating portion, and further wherein the aft balloonis secured to the sleeve proximal to the articulating portion of thesteerable endoscope.
 33. A method according to claim 21 wherein the aftballoon comprises a body having a proximal opening and a distal opening,a distal extension extending distally from the body, a proximalextension extending proximally from the body, and further wherein theaft balloon is formed by everting the distal extension into an interiorof the body and into an interior of the proximal extension.
 34. A methodaccording to claim 21 wherein the raised push tube bridge comprises anatraumatic tip.
 35. A method according to claim 24 further comprising apush tube handle secured to the proximal ends of the hollow push tubes,and further wherein the base is configured to support and guide the pushtube handle as the push tube handle is used to move the pair of hollowpush tubes relative to the sleeve.
 36. A method according to claim 21wherein the fore balloon comprises a body having a proximal opening anda distal opening, a proximal extension having a key-shaped cross-sectioncomprising a pair of lobes, and a distal extension having a circularcross-section, and further wherein the fore balloon is formed byeverting the distal extension into an interior of the body and into aninterior of the proximal extension.
 37. A method according to claim 36wherein the pair of hollow push tubes are disposed in the lobes beforethe distal extension is everted into the interior of the body.
 38. Amethod according to claim 36 wherein at least one extruded insert isdisposed adjacent to the lobes.
 39. A method according to claim 21wherein at least one of the sleeve, the aft balloon, the pair of hollowpush tubes and the fore balloon comprises a visualizable marker.
 40. Amethod according to claim 21 further comprising an inflation mechanismfor selectively inflating/deflating a selected one of the fore balloonand the aft balloon.